comparison between magnesium sulfate and …
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1
COMPARISON BETWEEN MAGNESIUM SULFATE AND
DEXMEDETOMIDINE IN CONTROLLED HYPOTENSION DURING
FUNCTIONAL ENDOSCOPIC SINUS SURGERY
Dissertation submitted to the
THE TAMIL NADU DR.M.G.R. MEDICAL UNIVERSITY
in partial fulfilment for the award of the degree of
DOCTOR OF MEDICINE
In
Anaesthesiology
BRANCH X
INSTITUTE OF ANAESTHESIOLOGY AND CRITICAL CARE
MADRAS MEDICAL COLLEGE
CHENNAI-600003
May 2020
Registration number - 201720016
2
CERTIFICATE OF THE GUIDE
This is to certify that the dissertation titled “COMPARISON BETWEEN
MAGNESIUM SULFATE AND DEXMEDETOMIDINE IN CONTROLLED
HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY”
is a bonafide research work done by Dr. SRIRAM SUNDAR. M in partial fulfilment
of the requirement for the degree of DOCTOR MEDICINE in Anaesthesiology.
Prof. Dr. Vellingiri M, M.D., D.A.,
Professor of Anaesthesiology,
Institute of Anaesthesiology and Critical Care,
Rajiv Gandhi Govt. General Hospital,
Madras Medical College,
Chennai -03.
DATE:
PLACE:
3
CERTIFICATE
This is to certify that the dissertation titled, “COMPARISON BETWEEN
MAGNESIUM SULFATE AND DEXMEDETOMIDINE IN CONTROLLED
HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY”
submitted by DR. SRIRAM SUNDAR. M with registration number 201720016 in
partial fulfilment for the award of the degree of DOCTOR OF MEDICINE in
anaesthesiology by The Tamilnadu Dr.M.G.R medical university, Chennai is a
bonafide record of work done by him in the INSTITUTE OF ANAESTHESIOLOGY
& CRITICAL CARE, Madras Medical College, during the academic year 2017 -2020
.
Prof.Dr.ANURADHA SWAMINATHAN, Prof.Dr.JAYANTHI,
MD., DA., M.D., F.R.C.P(Glasg).,
Professor and Director, The Dean,
Institute of Anaesthesiology & Critical Care, Madras Medical College,
Madras Medical College, Rajiv Gandhi Govt. General
Rajiv Gandhi Govt General Hospital, Hospital,
Chennai – 600003. Chennai – 600003.
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DECLARATION
I hereby declare that the dissertation titled, “COMPARISON BETWEEN
MAGNESIUM SULFATE AND DEXMEDETOMIDINE IN CONTROLLED
HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC SINUS
SURGERY” has been prepared by me under the guidance of PROF.DR.
VELLINGIRI M, M.D., D.A., Professor of Anaesthesiology, INSTITUTE OF
ANAESTHESIOLOGY AND CRITICAL CARE, MADRAS MEDICAL
COLLEGE, CHENNAI, in partial fulfilment of the regulations for the award of
the degree of M.D (Anaesthesiology),examination to be held in May 2020. This
study was conducted at INSTITUTE OF ANAESTHESIOLOGY AND
CRITICAL CARE, MADRAS MEDICAL COLLEGE, CHENNAI.
I have not submitted this dissertation previously to any journal or any
university for the award of any degree or diploma.
DR. SRIRAM SUNDAR. M
Date:
Place: Chennai
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ACKNOWLEDGEMENT
I am extremely thankful to DR. JAYANTHI M.D., FRCP(Glasg)., Dean,
Madras Medical College, for her permission to carry out this study. I am immensely
grateful to PROF. DR. ANURADHA SWAMINATHAN, M.D., D.A., Director
and Professor, Institute of Anaesthesiology and Critical Care, for her concern and
support in conducting this study.
I am extremely grateful and indebted to my guide PROF. DR. VELLINGIRI,
MD., D.A., Professor, Institute of anaesthesiology and critical care for his concern,
inspiration, meticulous guidance, expert advice and constant encouragement in doing
and preparing this dissertation.
I am extremely thankful to my Assistant Professor DR. RAVI, DR. ASHA and
DR. RAJESHWARI for their constant motivation and valuable suggestions in doing
my study.
I am thankful to the Institutional Ethical Committee for their guidance and
approval for this study.
I am thankful to all my colleagues and friends for their help and advice in
carrying out this dissertation.
I am immensely thankful to all the patients who consented, without whom this
study couldn’t have been possible.
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CONTENTS
S.NO. INDEX PAGE NO
1. INTRODUCTION 1
2. AIMS AND OBJECTIVES 24
3. REVIEW OF LITERATURE 25
4. MATERIALS AND METHODS 40
5. OBSERVATON, RESULTS AND ANALYSIS 45
6. SUMMARY 75
7. DISCUSSION 76
8. CONCLUSION 78
9. BIBLIOGRAPHY 79
10. ANNEXURE
a.Ethical committee approval
b.Antiplagiarism – URKUND copy
c.Plagiarism certificate
d.Proforma
e.Patient Consent Form
f.Patient Information Form
g.Master Chart
1
INTRODUCTION
Functional endoscopic sinus surgery is a commonly performed surgery
worldwide for various indications. It is the preferred surgical treatment for chronic
rhinosinusitis. In part due to being an endoscopic procedure and in part due to being a
procedure done in an enclosed space, bleeding during functional endoscopic sinus
surgery is a major detriment to visibility during the procedure. In addition to that,
excessive bleeding might result in prolonged surgery, hypotension and might require
blood transfusion, associated with its own demerits. Anaesthesiologists find it
imperative to reduce bleeding during functional endoscopic sinus surgery to improve
visibility. One of the techniques used is controlled hypotension. By carefully reducing
the blood pressure, one can decrease blood loss and need for blood transfusion,
improve surgical site visibility.
2
DEXMEDETOMIDINE
3
Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist. Its
multitude of effects include sedation, anxiolysis, and analgesia without respiratory
depression. It also has synergistic action on the anaesthesia produced by other
anaesthetic drugs. Chemical name of Dexmedetomidine is (+)-4-(2,3
dimethylephenyl) ethyl – 1 H-imidazole monohydrochloride. Its molecular weight is
236.7 g/mol. Dexmedetomidine is the dextrorotatory S-enantiomer of medetomidine.
C13H16HCl is its empirical formula. [29]
Pharmacodynamics
Alpha 2 receptor agonists act on G-protein coupled alpha 2 receptors (3
subtypes – α2A, α2B, α2C) and produce different pharmacological activities. These
receptor subtypes are found in central, peripheral and autonomic nervous systems,
vital organs and blood vessels. Compared to clonidine, Dexmedetomidine is 8 to 10
times more selective towards α2A receptors (1620:1). Sedation may be due to its
action on post-synaptic α2 receptors. Dexmedetomidine also acts on beta adrenergic,
muscarinic, dopaminergic and serotonin receptors, but with low affinity. Analgesia is
believed to be due to action on α2 receptors of spinal cord. Higher affinity to α2
receptor selectively leads to bradycardia and vasodilatation because of vagomimetic
action.
4
Pharmacokinetics
Following intravenous administration, dexmedetomidine shows rapid
redistribution. The distribution t1/2 of dexmedetomidine is 6 minutes and a terminal
elimination t1/2 is approximately 2 hours. Protein binding capacity of
dexmedetomidine is 94%. Volume of distribution is 118L.
It exhibits poor oral bioavailability because of first pass metabolism.
Metabolism is by direct glucuronidation (major pathway) as well as cytochrome p450
mediated. Excretion is through urine and feces. It may need dose reduction in various
degrees of renal and hepatic impairment.
Availability and Routes of administration
Dexmedetomidine is available as Dexmedetomidine Hydrochloride injections,
50 µg/0.5ml, 100 µg/ml and 200 µg/2ml. Various routes of administration such as
intravenous, intramuscular, spinal, epidural, peripheral nerve blocks, buccal and
intranasal routes have been described.[5,12,20,36]
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Clinical Applications
1. Premedication
Dexmedetomidine is extremely useful as a premedication as it exhibits
sedative, analgesic and anxiolytic effects. Dose is 0.3-0.6 µg/kg iv given 15
minutes before surgery
2. Sedation
Dexmedetomidine has been described for sedation in both ICU and procedural
sedation. In ICU, Dexmedetomidine is indicated in mechanically ventilated
patients where it decreases the requirement of opioids while causing minimal
respiratory depression. It has been safely used in Transesophageal
echocardiography [13], colonoscopy [24], awake carotid endarterectomy [7],
shockwave lithotripsy [25], vitreoretinal surgery [18], MRI and CT scan in
paediatric patients. It has the major advantage of minimum respiratory
depression. Usual dose is 1 µg/kg in 100ml saline given over 10 minutes
followed by 0.2-0.7 µg/kg/hr.
3. Adjuvant in regional techniques
Dexmedetomidine is highly lipophilic which allows rapid absorption into CSF
and binding to α2 receptors on spinal cord. Duration of both sensory and motor
blockade induced by local anaesthetics has been prolonged by
dexmedetomidine irrespective of route of administration, spinal, caudal,
epidural, peripheral nerve block.
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4. Controlled hypotension
Dexmedetomidine is a safe agent for controlled hypotension. Mechanism of
action is by action on both central and peripheral α2 receptors resulting in
decrease in norepinephrine release and subsequent decrease in Arterial
pressure, heart rate and cardiac output. Its ease of administration, predictability,
apparently less toxic side effects and maintenance of vital organs perfusion
makes it a near ideal hypotensive agent.
5. Attenuation of response to tracheal intubation and extubation
Due to its sympatholytic action, Dexmedetomidine attenuates hemodynamic
stress response to tracheal intubation and extubation. [20]
6. Anaesthetic sparing effect
Intraoperatively, dexmedetomidine decreases requirement of anaesthetic agents
due to its sedative effects. Both intravenous and inhalational anaesthetic agents
are required in lesser amounts
7. Cardiac surgery
In addition to attenuation of stress response, dexmedetomidine appears to
reduce the extent of myocardial ischemia during cardiac surgery. It has been
found to be useful in CABG, vascular surgery and thoracic surgery.
8. Neurosurgery
Dexmedetomidine provides protection against sudden increase in intracranial
pressure. It has neuroprotective effects that are valuable during cerebral
ischemia. It has been used in cases requiring spinal monitoring by evoked
potentials by substituting for neuromuscular blocking agents. It has also been
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extensive used in the sedation phases of awake craniotomy for resection of
tumours/epileptic foci near important areas.
9. Awake intubation
Use of dexmedetomidine has been described for awake fibreoptic intubation for
securing the difficult airway. [8]
10. Postoperative analgesia
Dexmedetomidine provides very good postoperative analgesia. It reduces
postoperative analgesic requirement significantly.
11. Other uses
Dexmedetomidine has also been described as useful in paediatric patients,
obese patients, alcohol and drug withdrawal, as an antishivering agent,
intraarticularly, in palliative care and chronic pain management.
Adverse effects
Common adverse effects are
Hypotension
Hypertension
Bradycardia
Dry mouth
Nausea
Reversal
Atipamezole is an α2 receptor antagonist which reverses the sedative and
sympatholytic actions of dexmedetomidine in a dose dependent manner. [32]
8
MAGNESIUM SULFATE
Magnesium is an important component of many physiologic processes.
It has long been used in the field of anaesthesia and pain medicine. Magnesium is 4th
most common cation after sodium, potassium and phosphorus. Normal plasma range
is 1.4-2.2 mEq/L (0.7-1.1 mmol/L). Most important action of magnesium is blockade
of NMDA receptors and calcium channels. [16]
Physiological role
1. Acts as mediator for Na+/K+ pump, thereby maintaining transmembrane
potential
2. Generation of cyclic AMP via adenylyl cyclase
3. Release and action of parathyroid hormone
4. Oxidative phosphorylation, glucose utilization and protein synthesis
Homeostasis
Maintained by gastrointestinal absorption and renal excretion. Available in
diet. Mainly excreted by the kidneys, reabsorbed in the ascending loop of Henle.
Aldosterone inhibits renal excretion while parathormone increases gut absorption as
well as decreases renal excretion.
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System wise effects
1. Cardiovascular system
a. Direct depressant effect on myocardial and vascular smooth muscle.
b. Competes with Calcium at the presynaptic calcium channels and inhibits
release of catecholamines from the adrenal medulla, peripheral
adrenergic terminals and blocks adrenergic receptors directly as well.
c. Thus reducing pulmonary and systemic vascular resistance and causing
hypotension.
d. Slows the rate of SA node, prolongs SA conduction, prolongs PR
interval and refractory period of AV node. – Mechanism of
antiarrhythmic action
2. Nervous system
a. Reduces the release of acetylcholine at the neuromuscular junction by
competing with calcium at the presynaptic region.
b. Reduces excitability of nerves
c. Anticonvulsant
d. Reverses cerebral vasospasm
3. Musculoskeletal
a. Decrease release of acetyl choline
b. Causes termination of contraction, thereby marks the beginning of
relaxation in skeletal muscles
c. Muscle weakness in excessive concentrations
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4. Respiratory system
a. Magnesium behaves as an effective bronchodilator without affecting
respiratory drive
b. Respiratory failure in excessive concentrations.
5. Genitourinary system
a. Magnesium is a powerful tocolytic which decreases uterine tone and
contractility.
b. Mild diuretic properties
6. Hematological system
a. Reduces platelet activity resulting in prolonged bleeding time
Hypomagnesemia
Occurs frequently after surgery such as
cardiac surgery,
abdominal surgery
and orthopaedic surgery.
Other causes include,
decreased dietary intake or absorption,
hemodilution,
drug induced (diuretics, digoxin, cyclosporine etc),
hyperaldosteronism,
Diarrhoea,
NG drainage,
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hyperparathyroidism and
insulin administration.
Signs and symptoms include
chest pain,
palpitations,
arrhythmias,
muscle cramps,
stridor,
psychiatric disturbances and
ECG changes (PR prolongation and QT prolongation).
Treatment includes dietary supplementation and intravenous administration
(Magnesium sulfate contains 2 ml of 50% w/v solution – 1g / 2ml or 4mmols/2 ml).
Hypermagnesemia
Most common cause is iatrogenic as a result of intravenous therapy,
particularly in the setting of coexisting impaired renal excretion. Rarely may be due to
diabetic ketoacidosis and tumour lysis syndrome.
Clinical features are dependent on serum concentration.
4-5 mmol/L – Muscle weakness and loss of tendon reflexes
5-7.5 mmol/L respiratory paralysis
10-12.5 mmol/L cardiac arrest
12
Management includes
careful monitoring during intravenous administration of magnesium,
cessation of therapy,
intravenous fluids,
diuretics,
dialysis
Calcium gluconate intravenously
Clinical Uses
1. Eclampsia
Extensive research has given Magnesium sulfate the prime place in
management of eclamptic seizures. Mechanism for the same has not yet been
established. Possible mechanisms include
Cerebral vasodilatation
Blood brain barrier protection
Various anticonvulsant actions
2. Analgesia
Magnesium has been found to be an excellent adjuvant to most analgesic
agents, despite not being a primary analgesic by itself. Its action is believed to
be due to its blockade of NMDA receptors. Intraoperative magnesium sulfate
has been associated with decreased opioid requirement in the postoperative
period. Magnesium sulfate has also been indicated in regional anaesthesia via
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both intravenous and intrathecal route. Magnesium sulfate prolongs the
duration of analgesia following spinal anaesthesia.
3. Anaesthesia sparing effect
Due to its sedative effect, Magnesium sulfate has synergistic action and
decreases requirement of both intravenous and inhalational anaesthetic agents.
4. Potentiating nondepolarising neuromuscular blocking drugs
Due to its competitive antagonism of Ca++ at the presynaptic calcium channel
and subsequent decrease in acetylcholine release, Magnesium sulfate
potentiates neuromuscular blockade by non depolarising neuromuscular
blocking agents. In cases where neuromuscular blocking agents requirement is
increased, like, cerebral palsy, burns, intake of sodium valproate, Magnesium
sulfate helps in reducing the requirement of neuromuscular blocking agents
5. Shivering
Magnesium sulfate decreases the incidence of shivering by 70-90% [30].
Shivering increases oxygen consumption and postoperative discomfort which
can be prevented by use of magnesium sulfate
6. Attenuation of tracheal response
Magnesium sulfate decreases sympathetic neurotransmitter release by
competitively blocking presynaptic calcium channel, thereby decreasing
hemodynamic pressor response to various stresses like tracheal intubation,
extubation and laparoscopy. This property of magnesium sulfate is of particular
importance in preeclamptic, eclamptic, hypertensive and cardiac patients.
14
7. Controlled hypotension
Apart from decreasing sympathetic neurotransmitter release, Magnesium also
causes arterial dilatation by maintaining calcium inside the sarcoplasmic
reticulum. Major advantage of magnesium sulfate being maintenance of cardiac
output by maintaining β adrenergic activity (in presence of catecholamines) and
venous return.
8. Other uses due to sympatholysis
The sympatholytic actions of magnesium sulfate also makes it useful in
intraoperative hypertensive emergencies, management of a patient of
pheochromcytoma and severe tetanus
9. Antiarrhythmic
Even though magnesium sulfate is indicated only for Torsades de pointes, it is
also useful in other arrhythmias, particularly catecholamine induced
tachyarrhythmias and arrhythmias after cardiac surgery.
10. Status asthmaticus
Magnesium sulfate also has bronchodilatory properties which makes it one of
the last options during status asthmaticus not responding to usual management
strategies
11. Tocolytic
Magnesium sulfate has also been described as having tocolytic actions.
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CONTROLLED HYPOTENSION
Deliberately induced hypotension to reduce bleeding and to improve surgical
site visibility is called controlled hypotension. There is no fixed definition of
hypotension. It has been reported that there are 140 definitions of hypotension in
literature [9]. Most commonly described as reduction of systolic blood pressure to 80-
90mmHg or reduction of mean arterial pressure to 50-65mm Hg or a 30% reduction
from baseline MAP [15]. There has also been reports that decreases of 10-20% from
baseline MAP has been enough to decrease blood loss [11].
Indications
1. Cerebral aneurysm repair
2. Brain tumour resection
3. Endoscopic nasal surgeries
4. Middle ear surgeries
5. Total hip arthroplasty
6. Radical neck dissection
7. Radical cystectomy
8. Spine surgeries
9. Microscopic surgeries
10. Contraindications to transfusion (Non availability of blood, Jehovah’s witness etc)
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Techniques
1. Positioning (Reverse trendelenberg for head and neck surgeries)
2. PEEP
3. Regional anesthesia – Central neuraxial blockade
4. Pharamacological therapy
Ideal pharmacological agent – properties
1. Ease of administration
2. Predictable and dose dependent effect
3. Rapid onset/offset – Titratability
4. Quick elimination/ no toxic metabolites
5. Minimal effects on blood flow to vital organs
Agents
1. Inhalational agents
Mechanism of action – Inhalational anaesthetic agents decrease myocardial
contractility and cause systemic vasodilatation in a dose dependent manner.
Disadvantage – Decreases cardiac output
Cerebral vasodilation
2. Nitrodilators
Mechanism of action – Gives nitric oxide which activates guanylyl cyclase
and cGMP and produce vasodilatation
a. Sodium Nitroprusside
Disadvantage – Cyanide toxicity,
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Methemoglobinemia,
Coronary steal phenomenon,
Cerebral vasodilatation,
Abolishes hypoxic pulmonary vasoconstriction
b. Nitroglycerine
Disadvantage – Methemoglobinemia
Cerebral vasodilatation
Decrease hypoxic pulmonary vasoconstriction
Tachycardia – increased myocardial oxygen demand
3. Hydralazine
Disadvantage – Late onset, difficult to titrate
Cerebral vasodilatation
4. Fenoldopam
Disadvantage – Late onset, difficult to titrate
Increased intraocular pressure
5. Calcium channel blockers
a. Nicardipine
b. Clevidipine
6. ACE I inhibitors – Enalaprilat
7. α2 agonists
a. Clonidine
b. Dexmedetomidine
8. Magnesium sulfate
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Contraindications
1. Severe anemia
2. Hypovolemia
3. Coronary artery disease
4. Atherosclerosis
5. Peripheral vascular disease
6. Hepatic disease
7. Renal disease
8. Cerebrovascular disease
9. Uncontrolled glaucoma
Complications
1. Cerebral thrombosis
2. Paraplegia – decreased spinal cord perfusion
3. Acute kidney injury
4. Massive hepatic necrosis
5. Myocardial ischemia
6. Cardiac arrest
7. Metabolic acidosis
8. Blindness – Retinal artery thrombosis/Ischemic optic neuropathy
19
FUNCTIONAL ENDOSCOPIC SINUS SURGERY
FESS is a commonly performed ENT procedure for medically refractory
chronic rhinosinusitis and chronic polyps. It is done using an endoscope in a small
restricted area making bleeding a major impediment to the procedure
Choice of anaesthesia – Local vs General anaesthesia
FESS in the early period was done under local anaesthesia, as the patient can
alert the surgeon which can minimise trauma and complications. In current times,
evolution of technique has allowed the surgeon to be more aggressive in extent of
resection. Advantages of general anaesthesia include
1. Immobile surgical field
2. Effective airway protection
3. Adequate analgesia
4. Patient comfort
Minimising bleeding
Haemorrhage decreases surgical site visibility and is directly responsible for
procedural failure, prolonged surgery and increased risk of vascular, orbital and
intracranial complications. Hence, minimising bleeding becomes an important
responsibility of the anaesthesiologist. Surgical control of the bleeding is difficult
because of the extensive vascular supply in the region. Methods to decrease bleeding
include
20
Positioning
Reverse trendelenburg position upto 15º allows for venous decongestion of
head and neck regions aided by gravity.
Preoperative steroids
This is usually done in cases of severe polyposis as steroids have anti-
inflammatory action and decrease mucosal oedema
Injected and topical local anaesthetics and vasoconstrictors
Commonly used vasoconstrictors include cocaine, epinephrine and
phenylephrine.
Maintenance of anaesthesia depth
Coughing or straining of the patient will increase in mean arterial pressure and
increase in intrathoracic pressure thereby causing venous congestion in the upper part
of the body.
Controlled hypotension
Deliberately induced hypotension decreases capillary hydrostatic pressure
thereby decreasing capillary bleeding.
Attenuation of hemodynamic response to intubation and extubation
Sympathetic release in response to intubation and extuabtion will increase the
arterial pressure which will lead to increased bleeding.
21
Smooth emergence and reversal
Avoidance of straining will decrease post surgical bleeding, decrease the risk of
sore throat and patient discomfort. Decision must be made regarding the mode of
extubation – awake vs deep. Even though deep extubation prevents the stress induced
increase in post surgical bleeding, it increases the risk of aspiration and obstruction.
[35]
Postoperative nausea and vomiting
Contributing factors include
1. Blood in the stomach
2. Inflammation of uvula and throat
3. Use of opioids for pain control
Can be prevented by
1. Packing of throat
2. Decompression of stomach using orogastric tube before extubation
3. Prophylaxis with ondansetron and dexamethasone
22
ASSESSMENT OF BLEEDING IN FESS
Assessment of bleeding in FESS can be done by using the scale described by Fromme
et al [18] and Boezaart et al [10]. Evaluation is based on 6 point scale.
0 – No bleeding
1 – Mild bleeding, suction not necessary
2 – Mild bleeding, occasional suctioning required, non threatened surgical field
3 – Mild bleeding, frequent suctioning required, bleeding threatens surgical field few
seconds after suction
4 – Moderate bleeding, frequent suctioning required, bleeding threatens surgical site
immediately after suction
5 – Severe bleeding, continued suction needed, bleeding appears faster than it can be
removed by suction
23
MODIFIED RAMSAY SEDATION SCALE
SCORE CHARACTERISTICS
1 Awake and alert, minimal or no cognitive impairment
2 Awake but tranquil, purposeful responses to verbal commands at
conversational level
3 Appears asleep, purposeful responses to verbal commands at
conversational level
4 Appears asleep, purposeful responses to verbal commands but at
louder than conversational level or light glabellar tap
5 Asleep, sluggish purposeful responses only to loud verbal
commands or strong glabellar tap
6 Asleep, sluggish purposeful response only to painful stimuli
7 Asleep, reflex withdrawal to painful stimuli only
8 Unresponsive to external stimuli, including pain
2-3 Minimal sedation
4-5 Moderate sedation
6-8 Deep sedation [14]
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AIMS AND OBJECTIVES
To compare blood loss and surgical site visibility using controlled hypotension
by dexmedetomidine and magnesium sulfate during functional endoscopic sinus
surgery
SECONDARY OBJECTIVES
To compare
1. Satisfaction of the surgeon
2. Time taken to achieve desired mean arterial pressure
3. Total need of muscle relaxants
4. Attenuation of hemodynamic response to intubation and extubation
5. Postoperative sedation
6. Adverse effects
25
REVIEW OF LITERATURE
1. Adnan Bayram, Ayse Ulgey, Isin Gunes, Ibrahim Ketenci, Ayse Capar, Aliye
Esmaoglu, Adem Boyaci.
COMPARISON BETWEEN MAGNESIUM SULFATE AND
DEXMEDETOMIDINE IN CONTROLLED HYPOTENSION DURING
FUNCTIONAL ENDOSCOPIC SINUS SURGERY. Revista Brasileira De
Anestesiologia. 2015;65(1):61-67.
They conducted the study in 60 patients and concluded that the use of
dexmedetomidine at the doses mentioned in this study provided more effective
and stable controlled hypotension in patients undergoing Functional endoscopic
sinus surgery, besides increasing the surgeon’s satisfaction and the quality of
the surgical site, without prolonging the recovery period.
26
2. Akcan Akkaya, Umit Yasar Tekelioglu, Abdullah Demirhan, Murat Bilgi, Isa
Yildiz, Tayfun Apuhan, Hasan Kocoglu.
COMPARISON OF EFFECTS OF MAGNESIUM SULFATE AND
DEXMEDETOMIDINE ON SURGICA VISION QUALITY IN
ENDOSCOPIC SINUS SURGERY, Revista Brasileira de Anestesiologia,
Volume 64, No. 6, Nov-Dec 2014, DOI: 10.1016/j.bjane.2014.01.008
They conducted the study in 60 patients and concluded that due to its reduction
of bleeding and heart rate in endoscopic sinus surgery and its positive impacts
on the duration of surgery, we consider dexmedetomidine to be a good
alternative to magnesium
27
3. Omyma S.M. Khalifa, Osama G. Awad.
A COMPARATIVE STUDY OF DEXMEDETOMIDINE, MAGNESIUM
SULFATE OR GLYCERYL TRINITRATE IN DELIBERATE
HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC SINUS
SURGERY. Ain-Shams Journal of Anesthesiology, 2015, 08:320-326, DOI:
10.4103/1687-7934, 161692
They conducted the study in 60 patients and concluded that Dexmedetomidine,
Magnesium sulfate or glyceryl trinitrate induced deliberate hypotension, with
superior hemodynamic stability in dexmedetomidine. Analgesic and sedative
effects were obtained with dexmedetomidine and magnesium sulfate, but with
longer recovery and discharge times.
28
4. Hesameddin Modir, Amirreza Modir, Omid Rezaei, Abolfazi Mohammadbeigi.
COMPARING REMIFENTANIL, MAGNESIUM SULFATE AND
DEXMEDETOMIDINE FOR INTRAOPERATIVE HYPOTENSION AND
BLEEDING AND POSTOPERATIVE RECOVERY IN ENDOSCOPIC
SINUS SURGERY AND TYMPANOMASTOIDECTOMY. Med Gas Res.
2018 Apr-Jun; 8(2): 42-47, DOI: 10.4103/2045-9912.235124.
They conducted the study in 105 patients and concluded that the reduced
BP/HR, blood loss and the overall amount of propofol administered during
surgery in the dexmedetomidine group when compared to the other groups
indicates dexmedetomidine seems to be an effective choice with longer
postoperative recovery time.
29
5. Hyunzu Kim, Sang-Hee Ha, Chang-Hoon Kim, Sang-Hoon Lee, Seung-Ho
Choi.
EFFICACY OF INTRAOPERATIVE DEXMEDETOMIDINE INFUSION ON
VISUALIZATION OF THE SURGICAL FIELD IN ENDOSCOPIC SINUS
SURGERY. Korean J Anesthesiol. 2015 Oct; 68(5): 449-454, DOI:
10.4097/kjae.2015.68.5.449
They conducted the study in 43 patients and concluded that continuous
infusions of dexmedetomidine provide a similar visualisation of the surgical
field and hemodynamic stability as remifentanil target-controlled infusions in
patients undergoing endoscopic sinus surgery
30
6. Guven DG, Demiraran Y, Sezen G, Kepek O, Iskender A.
EVALUATION OF OUTCOMES IN PATIENTS GIVEN
DEXMEDETOMIDINE IN FUNCTIONAL ENDOSCOPIC SINUS
SURGERY. Ann Otol Rhinol Laryngol. 2011 Sep;120(9):586-92.
They conducted the study in 40 patients and concluded that intraoperative
bleeding, hemodynamic stability and VAS scores were better and the side
effects were less frequent in the dexmedetomidine group than control group.
31
7. Ossama H. Aboushanab, Ahmed M. El-Shaarawy, Ahmed M. Omar, Hisham
H. Abdelwahab.
A COMPARATIVE STUDY BETWEEN MAGNESIUM SULFATE AND
DEXMEDETOMIDINE FOR DELIBERATE HYPOTENSION DURING
MIDDLE EAR SURGERY. Egyptian Journal of Anaesthesia, 27:4, 227-232,
DOI: 10.1016/j.egja.2011.07.008
They conducted the study in 88 patients and concluded that both magnesium
sulfate and dexmedetomidine successfully induced deliberate hypotension and
good surgical field visibility but magnesium sulfate was associated with shorter
recovery time and earlier discharge from the PACU
32
8. Rabie Soliman, Eman Fouad.
THE EFFECTS OF DEXMEDETOMIDINE AND MAGNESIUM SULFATE
IN ADULT PATIENTS UNDERGOING ENDOSCOPIC TRANSNASAL
TRANSSPHENOIDAL RESECTION OF PITUITARY ADENOMA. Indian
Journal of Anaesthesia, 2017, Volume 61, Issue 5, Pages 410-417
They conducted the study in 152 patients and concluded that during
transsphenoidal pituitary resection, dexmedetomidine, compared to magnesium
sulfate is associated with lower blood loss and better operating conditions but
with more hypotension and bradycardia.
33
9. Ahmed Abdel Hakim Balata, Howaida Kamal Abdel Latif, Salwa Hassan
Waly, Ahmed Bahgat Mohamed.
DEXMEDETOMIDINE VERSUS MAGNESIUM SULFATE OR
LIDOCAINE FOR BLUNTING STRESS RESPONSE TO DIRECT
LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN
ABDOMINAL SURGERIES. Z.U.M.J.Vol. 24, No. 6, November 2018, DOI:
10.21608/zumj.2018.18288
They conducted the study in 87 patients and concluded that dexmedetomidine
and magnesium sulfate play an important role in blunting the stress response
resulting from direct laryngoscopy and intubation.
34
10. N.M. Elsharnouby, M.M. Elsharnouby.
MAGNESIUM SULFATE AS A TECHNIQUE OF HYPOTENSIVE
ANAESTHESIA. British Journal of Anaesthesia, Volume 96, Issue 6, June
2006, Pages 727-731.
They conducted the study in 60 patients and concluded that Magnesium sulfate
led to a reduction in arterial pressure, heart rate, blood loss and duration of
surgery. Furthermore, magnesium infusion alters anaesthetic dose requirements
and emergence time.
35
11. Ryu JH, Sohn IS, Do SH
CONTROLLED HYPOTENSION FOR MIDDLE EAR SURGERY: A
COMPARISON BETWEEN REMIFENTANIL AND MAGNESIUM
SULFATE. Br J Anaesth. 2009;103:490-495
They conducted the study in 80 patients and concluded that both magnesium
sulfate and remifentanil when combined with Sevoflurane provided adequate
controlled hypotension and proper surgical conditions for middle ear surgery.
However, patients administered magnesium sulfate had a more favourable
postoperative course with better analgesia and less shivering and PONV
36
12. Salmasi, V, Maheshwari, K, Yang, D, Mascha, EJ, Singh, A, Sessler, DI, Kurz,
A RELATIONSHIP BETWEEN INTRAOPERATIVE HYPOTENSION, DEFINED
BY EITHER REDUCTION FROM BASELINE OR ABSOLUTE THRESHOLDS,
AND ACUTE KIDNEY AND MYOCARDIAL INJURY AFTER NONCARDIAC
SURGERY: A RETROSPECTIVE COHORT ANALYSIS. ANESTHESIOLOGY
2017; 126:47–65
They conducted a retrospective cohort study and concluded that the
associations based on relative thresholds were no stronger than those based on
absolute thresholds. Furthermore, there was no clinically important interaction with
preoperative pressure. Anaesthetic management can thus be based on intraoperative
pressures without regard to preoperative pressure.
37
13. Song JW, Lee YW, Yoon KB, et al.
MAGNESIUM SULFATE PREVENTS REMIFENTANIL-INDUCED
POSTOPERATIVE HYPERALGESIA IN PATIENTS UNDERGOING
THYROIDECTOMY. ANESTH ANALG. 2011;113:390---7.
They conducted the study in 90 patients and concluded that a relatively high dose of
intraoperative remifentanil enhances periincisional hyperalgesia. Intraoperative
magnesium sulfate prevents remifentanil induced hyperalgesia. However,
hyperalgesia did not reach clinical relevance in terms of postoperative pain or
analgesic consumption in patients undergoing thyroidectomy.
38
14. Pei Yu Tan, Ruban Poopalalingam,
ANAESTHETIC CONCERNS FOR FUNCTIONAL ENDOSCOPIC SINUS
SURGERY. PROCEEDINGS OF SINGAPORE HEALTHCARE, 2014;VOLUME
23:NO 3: 246-253
They concluded that Functional endoscopic sinus surgery is a widely accepted
and increasingly popular procedure that is acceptable to patients who have medically
refractory rhino-sinusitits and enjoys a high success rate. For the anaesthetist, it
provides an interesting challenge to use the latest drugs and techniques available in
order to allow an optimal operating field while decreasing the risk of surgery and
improve patient safety and satisfaction.
39
15. G Guler, A Akin, E Tosun, E Eskitafloglu, A Mizrak, A Boyaci.
SINGLE DOSE DEXMEDETOMIDINE ATTENUATES AIRWAY AND
CIRCULATORY REFLEXES DURING EXTUBATION. ACTA ANAESTHESIOL
SCAND. 2005;49:1088–91.
They conducted the study in 60 patients and concluded that a single dose bolus
injection of Dexmedetomidine before tracheal extubation attenuates airway circulatory
reflexes during extubation
40
MATERIAL AND METHODS
This was a prospective, randomised study of 40 patients, with ASA physical
status ASA PS I-II, between 18-65 years of age, BMI < 35, planned for elective
functional endoscopic sinus surgery between April 2018 and September 2018. The
study was approved by the institute’s Ethical committee and informed consent was
obtained from the patients. Patients not willing for the study, with renal and hepatic
impairment, bleeding and coagulation disorders, history of allergy, those receiving
calcium channel blockers and receiving agents contraindicated for controlled
hypotension have been excluded from the study. Patients were allocated to two groups
(Group D and Group M) by random selection.
After arriving in the operating room, patients were connected to ASA standard
monitors (NIBP, ECG, spO2, ETCO2 and Temperature). Baseline MAP and Heart
rate were recorded. Monitoring was done every five minutes, with MAP and Heart
rate being recorded post induction, post intubation, at minutes 5, 10, 15, 30 and 45,
post extubation and 5 minutes post extubation. An intravenous line was secured and
intravenous fluids given according to Holliday Segar formula [23]. Patients received
supplemental oxygen, Inj. Glycopyrrolate 0.2mg and Inj. Midazolam 1mg
intravenously. Patients in Group M received a loading dose of 40mg/kg of magnesium
sulfate in 100ml NS 10 minutes before induction of anaesthesia. Patients in Group D
received a loading dose of 1µg/kg of Dexmedetomidine in 100 ml NS 10 minutes
before induction of anaesthesia.
After adequate preoxygenation, Inj Fentanyl 2µg/kg given for attenuation of
hemodynamic response to intubation and intraoperative analgesia. Induction of
41
anaesthesia was achieved by Inj. Thiopentone 3-5 mg/kg titrated till loss of eyelash
reflex. Inj. Atracurium 0.5 mg/kg given for achieving muscle paralysis. Intubation
done using appropriate size endotracheal tube and throat packing done. Nasal mucosa
infiltrated with 2 ml 2% lignocaine with 1:200000 Adrenaline 5 minutes before
incision. Anaesthesia maintained with Sevoflurane in oxygen-nitrous oxide mixture
and Inj. Atracurium 0.1 mg/kg. Total dose of Inj. Atracurium used during the surgery
noted. Volume controlled mechanical ventilation done with target ETCO2 of 35-40
mmHg. Skin temperature maintained above 32ºC.
Maintenance dose of magnesium sulfate 10-15mg/kg in Group M and
Dexmedetomidine 0.5-1 µg/kg in Group D started and titrated to achieve controlled
hypotension. Controlled hypotension was defined as MAP decrease of 20% - 30%
from baseline MAP. The target MAP between 20% - 30% was decided after revising
previous studies in which hypotension was induced to provide bloodless field and
studies regarding the hazard of tissue ischemia with induced hypotension [11,15,31].
Time taken to achieve 20% decrease in baseline MAP recorded. If 20% decrease is
not achieved within 15 minutes after maximum limit of maintenance dose, Inj.
Nitroglycerine infusion started and titrated to achieve required decrease in MAP. If
decrease in MAP was more than 30% despite minimum limit of maintenance dose,
Inj. Ephedrine 6 mg was given. Bradycardia was defined as fall in heart rate less than
20% of baseline or heart rate 50 beats/minute, whichever is lower and atropine 0.6 mg
administered in patients who developed bradycardia.
42
Infusion of Magnesium sulfate and Dexmedetomidine stopped at the end of
surgery. Inj. Ondansetron 0.1 mg/kg given 30 minutes before extubation. Inj.
Neostigmine (50 µg/kg) and Inj. Glycopyrrolate (10 µg/kg) were given to reverse the
effects of Inj. Atracurium after adequate spontaneous recovery of neuromuscular
blockade. Patients’ level of sedation post extubation was assessed using Modified
Ramsay sedation scale.
SCORE CHARACTERISTICS
1 Awake and alert, minimal or no cognitive impairment
2 Awake but tranquil, purposeful responses to verbal commands at
conversational level
3 Appears asleep, purposeful responses to verbal commands at
conversational level
4 Appears asleep, purposeful responses to verbal commands but at
louder than conversational level or light glabellar tap
5 Asleep, sluggish purposeful responses only to loud verbal
commands or strong glabellar tap
6 Asleep, sluggish purposeful response only to painful stimuli
7 Asleep, reflex withdrawal to painful stimuli only
8 Unresponsive to external stimuli, including pain
43
2-3 Minimal sedation
4-5 Moderate sedation
6-8 Deep sedation
Occurrence of shivering or otherwise was duly noted. Patients with modified
Aldrete score ≥ 9 [4] were transferred to the ward. Duration of surgery is noted as
time taken from loading dose of agent to extubation of patient.
Surgical site visibility was evaluated by the surgeon and communicated to by
the same. Evaluation was based on 6 point scale. [6,10,18]
0 – No bleeding
1 – Mild bleeding, suction not necessary
2 – Mild bleeding, occasional suctioning required, non threatened surgical field
3 – Mild bleeding, frequent suctioning required, bleeding threatens surgical field few
seconds after suction
4 – Moderate bleeding, frequent suctioning required, bleeding threatens surgical site
immediately after suction
5 – Severe bleeding, continued suction needed, bleeding appears faster than it can be
removed by suction
The degree of satisfaction of the surgeon was evaluated by a 4 points scale [6],
1 – little, 2 – moderate, 3 – good, 4- very good
44
STATISTICAL ANALYSIS
Data collected was entered in Microsoft Excel 2013. The collected data were
analysed with IBM.SPSS statistics software 23.0 Version.
To describe about the data descriptive statistics, frequency analysis and
percentage analysis were used for categorical variables and the mean & S.D
were used for continuous variables.
To find the significant difference between the bivariate samples in independent
groups, unpaired sample t-test was used.
To find the significance in categorical data, Chi-Square test was used.
Similarly if the expected cell frequency is less than 5 in 2×2 tables then Fisher's
exact test was used.
In all the above statistical tools the probability value of 0.05 is considered as
significant level.
45
OBSERVATION AND RESULTS
Table 1: Comparison of Age distribution among both groups
Groups
Total
2 -
value
P-value
Group D Group M
Age
21 - 30
yrs
Count 6 3 9
2.2095 0.53
% 30.0% 15.0% 22.5%
31 - 40
yrs
Count 8 7 15
% 40.0% 35.0% 37.5%
41 - 50
yrs
Count 3 6 9
% 15.0% 30.0% 22.5%
Above
50 yrs
Count 3 4 7
% 15.0% 20.0% 17.5%
Total
Count 20 20 20
% 100.0% 100.0% 100.0%
Difference in Age distribution in both groups was not statistically significant.
Hence age distribution in both groups was comparable.
46
Fig 1: Comparison of Age distribution among both groups
Table 2. Comparison of the study groups according to mean age
Groups N Mean S.D t-test P-value
Age
Group D 20 37 10
1.6670 0.1037
Group M 20 43 10
The difference in the mean age between the study groups was not statistically
significant. Hence the groups are comparable with regards to mean age.
0
1
2
3
4
5
6
7
8
9
21 - 30 yrs 31 - 40 yrs 41 - 50 yrs Above 50 yrs
Age distribution
Group D Group M
47
Fig 2: Comparison of mean age among both groups
0
5
10
15
20
25
30
35
40
45
50
Group D Group M
Me
an
Groups
Age
48
Table 3: Comparison of gender distribution among both groups
Groups
Total
2 -
value
P-value
Group D Group M
Sex
Female
Count 9 10 19
0.100 0.7515
% 45.0% 50.0% 47.5%
Male
Count 11 10 21
% 55.0% 50.0% 52.5%
Total
Count 20 20 20
% 100.0% 100.0% 100.0%
Difference in Gender distribution among the groups was not statistically
significant. Hence the gender distribution in both the groups was comparable.
49
Fig 3: Comparison of Gender distribution among both groups
0
2
4
6
8
10
12
Group D Group M
Gender distribution
Female Male
50
Table 4: Comparison of weight among both groups
Groups N Mean S.D t-test
P-
value
Weight
Group
D
20 58.0 11.6
1.0313 0.3089
Group
M
20 61.8 11.7
Comparison of mean weight among the groups was not statistically significant.
Hence weight distribution among both groups was comparable.
Fig 4: Comparison of weight among both groups
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
Group D Group M
Me
an
Groups
Weight
51
Table 5: Comparison of ASA physical status among Groups
Groups
Total 2 - value P-value
Group D Group M
ASA PS
I
Count 16 16 32
0.000 1.000
% 80.0% 80.0% 80.0%
II
Count 4 4 8
% 20.0% 20.0% 20.0%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
Comparison of distribution of ASA physical status among the groups was not
statistically significant. Hence the groups were comparable in regards to ASA
Physical status.
52
Fig 5: Comparison of ASA Physical status among both groups
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group D Group M
Pe
rce
nta
ge
ASA Physical status
I II
53
Table 6: Comparison of Duration of surgery among both groups
Groups N Mean S.D t-test
P-
value
Duration
Group
D
20 143 38
0.2180 0.828
Group
M
20 141 27
Comparison of mean duration of surgery among the groups was not statistically
significant. Hence duration of surgery was comparable in both groups and not
prolonged in either group.
Fig 6: Comparison of duration of surgery among both groups
0
20
40
60
80
100
120
140
160
Group D Group M
Me
an
Groups
Duration
54
Table 7: Comparison of MAP among both groups
Groups N Mean S.D t-test P-value
Baseline
Group D 20 99.3 8.3
0.4860 0.629
Group M 20 100.9 11.6
Post Induction
Group D 20 83.5 16.4
0.7370 0.467
Group M 20 86.7 9.8
Post Intubation
Group D 20 103.3 12.7
4.1550 0.0005
Group M 20 118.2 9.8
5 Mins
Group D 20 85.8 12.6
1.2170 0.231
Group M 20 90.2 10.1
10 Mins
Group D 20 80.1 9.3
1.1680 0.250
Group M 20 83.3 8.0
15 Mins
Group D 20 77.2 9.4
0.6960 0.491
Group M 20 79.2 9.2
30 Mins
Group D 20 74.3 6.7
0.7840 0.438
Group M 20 76.0 7.0
45 Mins
Group D 20 74.2 6.4
0.6100 0.546
Group M 20 75.6 7.5
Post Extubation
Group D 20 99.7 8.0
2.8330 0.007
Group M 20 109.3 12.9
Post Extubation 5 Mins
Group D 20 92.8 6.9
1.7370 0.090
Group M 20 98.2 11.9
55
Difference in baseline MAP was not statistically significant. Hence the groups
were comparable with regards to Baseline MAP.
Difference in MAP during the Post intubation period and Post extubation
period was statistically significant. Hence Group D had less increase of MAP
compared to Group M post intubation and post extubation.
Differences in MAP during post induction, 5 minutes, 10 minutes, 15 minutes,
30 minutes and 45 minutes post intubation and 5 minutes post extubation were not
statistically significant. Both groups were comparable with regards to MAP during
post induction, intraoperative period and 5minutes post extubation.
Fig 7 Comparison of MAP among groups
020406080
100120140
Me
an
Groups
MAP
Group D Group M
56
Table 8: Comparison of Heart rate among both groups
Groups N Mean Std.
Deviation t-test P-value
Baseline
Group D 20 86.7 18.3
0.0660 0.948
Group M 20 87.0 15.1
Post Induction
Group D 20 85.0 15.7
1.0670 0.293
Group M 20 89.7 11.9
Post intubation
Group D 20 95.7 12.5
2.3301 0.025 Group M 20 103.6 8.8
5 Mins
Group D 20 86.4 14.2
0.0360 0.972 Group M 20 86.6 12.4
10 Mins Group D 20 83.2 14.8
0.2380 0.813
Group M 20 82.2 10.0
15 Mins
Group D 20 78.5 13.7
0.3020 0.764
Group M 20 79.7 11.3
30 Mins
Group D 20 78.3 10.8
0.1780 0.860
Group M 20 77.7 10.5
45 Mins
Group D 20 74.1 9.5
0.6060 0.548 Group M 20 75.9 9.8
Post Extubation
Group D 20 88.5 11.1
2.8720 0.007 Group M 20 98.4 10.8
Post Extubation 5
Mins
Group D 20 78.6 11.3 3.3430 0.002
Group M 20 89.6 9.3
57
Difference in baseline Heart rate was not statistically significant. Hence
the groups were comparable with regards to Baseline MAP.
Differences in Heart rate during the Post intubation period, Post extubation
period and 5 minutes post extubation were statistically significant. Hence Group D
had less increase of Heart rate compared to Group M post intubation, post extubation
and 5 minutes post extubation.
Differences in heart rate during post induction, 5 minutes, 10 minutes, 15
minutes, 30 minutes and 45 minutes post intubation were not statistically significant.
Both groups were comparable with regards to heart rate during post induction and the
intraoperative period.
Fig 8. Comparison of heart rate among groups
0
20
40
60
80
100
120
Me
an
Groups
Heart Rate
Group D Group M
58
Table 9: Comparison of bleeding scores among both groups
Bleeding score
Groups
Total
2 -
value
P-value
Group D Group M
I
Count 11 3 14
7.1048 0.0287
% 55.0% 15.0% 35.0%
2
Count 7 14 21
% 35.0% 70.0% 52.5%
3
Count 2 3 5
% 10.0% 15.0% 12.5%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
Difference in bleeding scores of both groups was statistically significant.
Group D had lower bleeding scores when compared with Group M.
59
Fig 9: Comparison of bleeding scores among both groups
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group D Group M
Pe
rce
nta
ge
Groups
Bleeding Score
1 2 3
60
Table 10: Comparison of Surgeon satisfaction among both groups
Surgeon Satisfaction
Groups
Total
2 -
value
P-value
Group D Group M
2
Count 4 6 10
7.2214 0.027
% 20.0% 30.0% 25.0%
3
Count 5 11 16
% 25.0% 55.0% 40.0%
4
Count 11 3 14
% 55.0% 15.0% 35.0%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
The difference in surgeon satisfaction among both the groups was statistically
significant. Group D had higher surgeon satisfaction score than Group M.
61
Fig 10: Comparison of Surgeon satisfaction among both groups
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group D Group M
Pe
rce
nta
ge
Surgeon Satisfaction with Groups
2 3 4
62
Table 11: Comparison of time taken to achieve 20% decrease in MAP
Time to achieve 20% decrease Group D
Group
M
Total
2 -
value
P-value
0-5mins
Count 4 2 6
2.628 0.453
% 20.0% 10.0% 15.0%
5-10mins
Count 7 4 11
% 35.0% 20.0% 27.5%
10-15mins
Count 6 10 16
% 30.0% 50.0% 40.0%
>15mins
Count 3 4 7
% 15.0% 20.0% 17.5%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
The difference in time taken to achieve 20% decrease in MAP is not
statistically significant. Time taken to achieve 20% decrease in MAP was comparable
in both groups.
63
Fig 11: Comparison of time taken to achieve 20% decrease in MAP
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group D Group M
Pe
rce
nta
ge
Groups
Time to Achieve 20% Decrease in MAP
0-5mins 5-10mins 10-15mins >15mins
64
Table 12: Comparison of need for NTG in both groups
Need for NTG
Groups
Total
2 -
value
P-value
Group D
Group
M
No
Count 17 16 33
0.173 1.000 #
% 85.0% 80.0% 82.5%
Yes
Count 3 4 7
% 15.0% 20.0% 17.5%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
There was no statistically significant difference in need for NTG among the
two groups. Need for NTG was comparable in both groups.
65
Fig 12: Comparison of need for NTG in both groups
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group D Group M
Pe
rce
nta
ge
Groups
Need for NTG
No Yes
66
Table 13: Comparison of Atracurium need among both groups
Groups N Mean S.D t-test P-value
Atracurium dose
Group D 20 52.8 11.4
2.2710 0.029
Group M 20 45.0 10.1
There was statistical significance in Atracurium need among both groups.
Group M had statistically significant decrease in Atracurium need compared to Group
D.
Fig 13: Comparison of Atracurium need among both groups
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
50.0
55.0
60.0
Group D Group M
Me
an
Atracurium dose
67
Table 14: Comparison of postoperative sedation among both groups
Modified Ramsay
sedation scale
Groups
Total
2 -
value
P-value
Group D Group M
2
Count 9 13 22
2.327 0.507
% 45.0% 65.0% 55.0%
3
Count 9 6 15
% 45.0% 30.0% 37.5%
4
Count 1 1 2
% 5.0% 5.0% 5.0%
5
Count 1 0 1
% 5.0% 0.0% 2.5%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
The differences in the modified Ramsay sedation scale among the two groups
were not statistically significant. Postoperative sedation was comparable in both
groups.
68
Fig 14: Comparison of postoperative sedation among both groups
0
2
4
6
8
10
12
14
2 3 4 5
Modified Ramsay sedation scale
Group D Group M
69
Table 15: Comparison of bradycardia among both groups
Bradycardia
Groups
Total
2 -
value
P-value
Group D Group M
No
Count 17 20 37
3.243 0.231
% 85.0% 100.0% 92.5%
Yes
Count 3 0 3
% 15.0% 0.0% 7.5%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
The difference in incidence of bradycardia in both groups was not statistically
significant. The incidence of bradycardia is comparable in both groups.
70
Fig 15: Comparison of bradycardia among both groups
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group D Group M
Pe
rce
nta
ge
Groups
Bradycardia with Groups
No Yes
71
Table 16: Comparison of hypotension among both groups
Hypotension
Groups
Total
2 -
value
P-value
Group D Group M
No
Count 18 20 38
2.105 0.487 #
% 90.0% 100.0% 95.0%
Yes
Count 2 0 2
% 10.0% 0.0% 5.0%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
The difference in the incidence of hypotension in both groups was not
statistically significant. The incidence of hypotension in both groups was comparable
72
Fig 16: Comparison of hypotension among both groups
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group D Group M
Pe
rce
nta
ge
Groups
Hypotension with Groups
No Yes
73
Table 17: Comparison of shivering among both groups
Shivering
Groups
Total
2 -
value
P-value
Group D Group M
No
Count 19 19 38
0.000 1.000#
% 95.0% 95.0% 95.0%
Yes
Count 1 1 2
% 5.0% 5.0% 5.0%
Total
Count 20 20 40
% 100.0% 100.0% 100.0%
The difference in incidence of shivering among both groups was not
statistically significant. The incidence of shivering was comparable in both groups.
74
Table 17: Comparison of shivering among both groups
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group D Group M
Pe
rce
nta
ge
Groups
Shivering with Groups
No Yes
75
SUMMARY
In our study conducted to compare Dexmedetomidine and magnesium sulfate
in controlled hypotension during functional endoscopic sinus surgery, the following
observations were statistically significant
1. Patients in Group D had statistically significant less increase of MAP compared
to those in Group M post intubation (103.3 vs. 118.2) and post extubation (99.7
vs. 109.3).
2. Patients in Group D had statistically significant less increase of Heart rate
compared to those in Group M post intubation (95.65 vs. 103.6), post
extubation (88.5 vs. 98.4) and 5 minutes post extubation (78.6 vs. 89.6).
3. Patients in Group D had lower bleeding scores when compared with those in
Group M.
4. Patients in Group D had higher surgeon satisfaction scores when compared
with those in Group M
5. Patients in Group M had statistically significant lesser need for Atracurium
intraoperatively when compared with those in Group D (45 vs. 52.8)
76
DISCUSSION
FESS is an endoscopic surgical procedure which requires an endoscope to do
all necessary manipulations. During the procedure, even small amount of bleeding
will reduce visibility, hence bleeding must be minimised. Various approaches have
been used. Here, we compare dexmedetomidine and magnesium sulfate in providing
controlled hypotension to minimise bleeding.
In our study, no significant difference was found in terms of age, weight,
gender, physical status. This study revealed that dexmedetomidine was better in
performing controlled hypotension during Functional endoscopic sinus surgery
compared to magnesium sulfate by proving that it provided better surgical site
visibility and surgeon satisfaction, as observed by Adnan Bayram et al [6] and Ackan
Akkaya [3]. The necessity of nitroglycerine was not less, in patients receiving
Dexmedetomidine when compared with patients receiving magnesium sulfate, though,
as observed by Adnan Bayram et al [6].
In our study, there was no significant difference in duration of surgery, similar
to Akkaya et al [3], Aboushanab et al [1] and Modir et al [28]. The difference in time
taken to achieve the desired MAP was not statistically significant among both groups,
unlike the observation made by Omyma S.M. Khalifa et al [26]. There was significant
difference in total dose of atracurium required with patients in Group M requiring
lesser dose than those in Group D. This was dissimilar to the observation by Rabie
Solimon et al [33].
77
When comparing the intraoperative MAP and heart rate, there was no statistical
difference in the baseline values, indicating that the two groups were comparable. The
intraoperative values were also not significantly different except the post intubation
and post extubation periods, signifying that Dexmedetomidine attenuated the
hemodynamic stress response to tracheal intubation and extubation better than
magnesium sulfate.
Comparison of postoperative sedation scores was not statistically significant,
unlike results in other studies [1,26,28]. There was no significant difference in the
incidence of bradycardia and hypotension unlike the observations made by Rabie
Solimon et al [33]
We did not include a control group in the study as the surgeons requested
deliberate hypotension for all patients.
78
CONCLUSION
We conclude that Dexmedetomidine when used in the doses mentioned in this
study provided controlled hypotension in a more effective manner than magnesium
sulfate in patients undergoing functional endoscopic sinus surgery, by providing
increased surgical site visibility and surgeon satisfaction, while also having the added
advantage of better attenuation of hemodynamic stress response to tracheal intubation
and extubation, without prolonged recovery period or increased risk of complications.
Therefore, we recommend the use of Dexmedetomidine as a safe agent to produce
controlled hypotension to minimise bleeding in patients undergoing FESS.
79
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A Relationship between intraoperative hypotension, defined by either
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7
ANNEXURE
8
9
PLAGIARISM CERTIFICATE
This is to certify that this dissertation work titled COMPARISON
BETWEEN MAGNESIUM SULFATE AND DEXMEDETOMIDINE IN
CONTROLLED HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC
SINUS SURGERY of the candidate Dr. Sriram Sundar. M with registration
number 201720016 for the award of MD degree in the branch of Anaesthesiology. I
personally verified the urkund.com website for the purpose of plagiarism check. I
found that the uploaded thesis file contains from introduction to conclusion pages and
result shows 14 % percentage of plagiarism in the dissertation.
Guide & Supervisor
DR. Vellingiri. M, M.D., D.A.,
Professor,
Institute of Anaesthesiology and Critical Care,
Madras Medical College
Chennai.
10
11
12
13
14
INFORMATION TO PARTICIPANTS
Investigator : Dr. Sriram Sundar. M
Name of the Participant:
Title : “COMPARISON BETWEEN MAGNESIUM SULFATE AND
DEXMEDETOMIDINE IN CONTROLLED HYPOTENSION DURING
FUNCTIONAL ENDOSCOPIC SINUS SURGERY"
You are invited to take part in this research study. We have got approval from the
IEC. You are asked to participate because you satisfy the eligibility criteria. We want
to compare and study the efficacy of MAGNESIUM SULFATE AND
DEXMEDETOMIDINE in producing controlled hypotension to minimise bleeding
during Functional endoscopic sinus surgery.
What is the Purpose of the Research:
To compare
1. Blood loss by surgical site visibility
2. Satisfaction of surgeon
3. Time taken to achieve desired mean arterial pressure
4. Total need of muscle relaxants
5. Attenuation of hemodynamic response to intubation and extubation
6. Postoperative sedation
7. Adverse effects
15
The Study Design:
All the patients in the study will be divided into two groups.
Group D – Dexmedetomidine 1 µg/kg in 100ml loading dose over 10 minutes
followed by 0.5-1 µg/kg/min maintenance
Group M – Magnesium sulfate 40mg/kg in 100 ml loading dose over 10 minutes
followed by 10-15 mg/kg/hr maintenance
All patients will be given general anaesthesia.
Benefits
Dexmedetomidine and Magnesium sulfate decrease blood loss thereby
reducing the chances of hypotension and need for blood transfusion, improve surgical
site visibility thereby decreasing the duration of surgery and associated complications.
Discomforts and risks
Hypotension
Bradycardia
Sedation
16
This intervention has been shown to be well tolerated as shown by previous
studies. And if you do not want to participate you will have alternative of setting the
standard treatment and your safety is our prime concern.
Time:
Date: Signature / Thumb Impression of Patient
Place: Patient Name:
Signature of the Investigator : ____________________________
Name of the Investigator : ____________________________
MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR
1 26 M 70 I 190 96 91 73 103 112 105 86 100 89 91 77 73 77 72 77 70
2 32 F 59 I 155 99 72 97 73 101 70 88 77 81 75 72 71 72 78 75 79
3 55 M 74 I 90 106 65 71 99 101 107 95 69 84 68 83 69 79 70 71 69
4 50 M 72 I 140 101 91 95 98 107 92 86 92 79 91 82 85 79 80 77 79
5 21 F 55 I 150 100 113 55 85 88 104 62 93 67 90 62 87 80 89 79 84
6 55 M 62 I 235 95 61 94 57 81 80 84 81 73 57 75 53 73 59 76 60
7 40 M 62 II 100 112 84 79 82 94 101 72 82 66 76 68 79 57 71 65 66
8 26 F 40 I 135 92 71 84 78 121 99 127 97 108 107 102 103 71 89 68 67
9 32 F 60 II 100 90 64 70 65 91 78 93 50 81 57 61 58 63 60 66 63
10 53 M 55 I 125 85 59 63 60 86 91 84 70 70 63 78 55 68 66 68 56
11 38 F 40 II 185 115 102 94 110 110 116 86 96 80 93 75 80 76 85 79 84
12 28 F 37 I 200 93 94 93 100 135 100 76 110 79 96 84 86 75 85 75 84
13 27 F 59 II 160 105 87 104 86 94 91 88 95 81 84 84 83 85 80 83 79
14 48 M 73 I 150 98 96 73 75 107 100 86 88 77 87 78 86 75 79 73 76
15 28 F 50 I 155 108 98 109 100 98 81 95 81 93 77 90 75 85 92 87 75
16 37 M 69 I 125 91 103 72 87 108 104 77 90 76 89 76 81 73 82 72 77
17 32 M 58 I 105 89 77 96 75 111 86 76 78 75 77 70 75 71 73 71 71
18 37 F 40 I 135 101 129 53 109 110 118 80 110 78 113 68 108 71 103 62 96
19 37 M 57 I 110 99 95 97 85 100 99 84 89 79 90 77 83 75 80 80 78
20 41 M 67 I 115 111 81 98 73 111 91 90 80 85 82 81 79 80 72 80 68
30 mins 45 mins
GROUP-D
10 mins 15 mins
S.No Age Sex Weight ASA PS
Baseline Post Post 5 mins
Duration
MAP HR MAP HR
93 91 91 84 10-15mins 3 2 no 3 70 no no no
105 87 95 67 10-15mins 2 3 no 3 50 no no yes
97 82 89 74 5-10mins 2 4 no 3 50 no no no
98 91 90 88 5-10mins 2 4 no 2 55 no no no
103 103 97 89 0-5 1 4 no 2 50 no no no
109 75 96 72 5-10mins 2 4 no 4 40 no no no
77 86 89 85 0-5 1 4 no 2 55 no yes no
95 75 93 73 >15mins 3 2 yes 2 45 yes no no
104 89 95 62 10-15mins 1 3 no 2 50 yes yes no
88 88 81 61 >15mins 2 2 yes 2 35 no no no
103 80 80 69 0-5 1 4 no 3 35 no no no
112 69 105 70 >15mins 1 4 yes 5 55 no no no
102 83 100 79 5-10mins 2 4 no 2 50 no no no
99 88 91 79 5-10mins 1 4 no 3 70 no no no
110 115 106 101 10-15mins 1 3 no 3 55 yes no no
104 95 100 76 10-15mins 2 2 no 3 50 no no no
100 83 90 75 10-15mins 1 3 no 3 55 no no no
93 110 84 104 0-5 1 4 no 2 40 no no no
100 90 91 83 5-10mins 1 4 no 2 70 no no no
101 89 93 81 5-10mins 1 3 no 3 75 no no no
Shivering
Atracurium
dose
Post 5 mins Bleeding
score
Surgeon
Satisfaction
Need for
NTG
Modified ramsay
sedation score
Time to
achieve 20%
Brady
cardia
Hypo
tension
MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR
1 28 M 58 I 185 100 103 79 93 108 108 87 103 88 88 92 82 72 76 80 70 103 101
2 58 F 51 I 140 101 77 92 83 130 90 91 85 85 87 75 85 77 83 76 77 104 100
3 55 M 52 I 170 98 64 88 82 102 102 89 89 88 90 87 92 78 84 79 84 110 106
4 57 F 57 I 120 90 81 79 75 116 92 81 83 79 77 72 76 71 75 72 74 98 103
5 30 M 62 I 160 97 96 89 97 126 118 110 110 85 95 76 101 77 92 78 89 119 116
6 32 F 49 I 145 90 100 78 111 108 109 80 90 68 82 67 75 69 75 68 80 110 98
7 55 M 65 I 145 126 83 101 81 127 101 113 71 103 72 102 70 88 66 87 59 132 100
8 50 F 45 II 105 106 103 91 101 133 110 101 102 82 99 85 100 73 100 74 91 106 125
9 49 M 70 II 105 99 126 91 111 117 114 72 100 68 100 73 98 73 97 79 92 120 106
10 38 F 55 I 140 75 94 68 98 112 112 96 83 80 84 68 71 57 74 52 71 95 99
11 50 M 60 II 105 121 66 77 70 123 99 83 58 83 63 85 64 83 64 79 62 131 77
12 40 M 61 II 135 110 66 82 70 122 95 91 74 86 71 84 68 80 66 72 65 85 87
13 37 F 55 I 120 111 91 100 96 132 100 92 92 82 87 80 86 79 85 78 88 118 95
14 32 M 90 I 190 105 92 102 100 120 105 89 74 86 69 80 68 83 68 81 69 96 90
15 48 F 62 I 125 89 82 80 87 111 94 79 81 73 78 69 76 71 77 70 79 108 97
16 44 M 55 I 155 100 92 77 85 114 113 95 90 91 85 88 81 79 77 80 77 103 85
17 38 F 83 I 115 109 79 101 91 131 101 89 93 82 86 78 85 81 86 80 80 107 92
18 29 M 68 I 125 105 84 95 86 121 114 98 89 92 71 83 67 85 64 85 63 133 90
19 35 F 81 I 150 93 71 83 80 109 88 83 75 81 79 68 74 70 73 69 77 107 106
20 45 F 56 I 180 92 90 80 97 102 107 84 89 83 81 72 74 73 71 72 71 100 95
15 minsBaseline Post Post 5 mins 10 mins 30 mins 45 mins Post
GROUP M
S.No Sex Weight ASA PS DurationAge
MAP HR
100 95 >15mins 2 2 yes 2 35 no no no
97 91 10-15mins 2 3 no 3 35 no no no
101 95 >15mins 3 2 yes 2 50 no no no
89 94 10-15mins 2 3 no 2 40 no no no
100 101 10-15mins 2 2 no 2 40 no no no
106 89 10-15mins 2 2 no 2 35 no no no
127 94 10-15mins 2 3 no 2 40 no no no
78 89 5-10mins 1 3 no 2 40 no no no
117 117 0-5mins 2 4 no 2 60 no no no
78 87 >15mins 2 2 yes 3 35 no no no
114 81 0-5mins 2 4 no 2 35 no no no
83 80 5-10mins 2 4 no 3 40 no no yes
98 86 5-10mins 2 3 no 2 45 no no no
94 84 10-15mins 3 3 no 4 70 no no no
101 88 10-15mins 2 3 no 2 45 no no no
95 81 >15mins 2 2 yes 2 40 no no no
98 83 5-10mins 2 3 no 2 55 no no no
98 74 10-15mins 1 3 no 3 55 no no no
95 97 10-15mins 1 3 no 3 60 no no no
94 85 10-15mins 3 3 no 3 45 no no no
5 mins Time to
achieve 20%
Brady
cardia
Hypo
tension
Shiverin
g
Surgeon
Satisfaction
Need for
NTG
Modified Ramsay
sedation score
Atracurium
dose
Bleeding
score