Conscious

(or should that really be unconscious)

sedation in G.I. Endoscopy

Memphis November 2011

Potpourri of GI sedation

Complications of GI endoscopic Sedation

Medico-Legal Issues

Patient Assessment and Monitoring

Sedation Vs Sedation Free Endoscopy

Difficult to sedate Patients

Propofol

‘National Study of Cardiopulmonary Unplanned Events after GI endoscopy’ (Sharma,VK et al Gastointest’ Endosc’ 2007 - Retrospective CORI database review) 8

325,000 procedures --- 0.9% CUEs

• EGDs 141,000 --- 0.6% CUEs

• Colonoscopies 175,000 ---- 1.1% CUEs

• ERCP 6100 ---- 2.1% CUEs

• EUS 3700 ---- 0.9% CUEs

39 deaths ( 11/100,000), 28 due to CUE’s ( 8/100,000 or 0.008%)-- 1/4 rate of other studies (Death rate from CUE’s 30/100,000 Arrowsmith, Gastrointest Endosc’ 1991)9

1:3,000 - 1: 12,500 Endoscopy Patients die from CUE’s

~1:100 CUE’s result in death. (Curr Opin Anesthesiol 2006)10

Most damaging and common endoscopy related CUE’s are inadequate oxygenation and ventilation from airway management problems and aspiration

•~1/3,000 --- 1/12,500 endoscopy patients die from CUE’s.

Propofol Safety Worldwide

646,080 endoscopist delivered propofol endoscopic cases worldwide

(Rex et al Gastroenterology 2009 ) 29

11 Intubations, 0 permanent Neurological Injuries, 4 deaths

0.1% of cases needed bag mask ventilation

The estimated cost per life saved to substitute anesthesia specialists in this study

assuming they would have prevented all deaths would be $ 5. 3 million. Complication rate was similar to that for General Anesthesia delivered by Anesthetists.

Risk Factors for Cardiopulmonary Unplanned Events During Endoscopy

ASA status (ASA IV- OR 3.2)

Patient age

Pulmonary Disease

Supplemental O2 (OR 1.2 for EGD’s)

Inverse relationship to dose of sedating medication(? increased sensitivity)

•Emergency cases

Litigation in U.S Gastroenterology

1% of all Medical litigation is Gastroenterology related. 40% procedure misadventure claims (Gastroenterology 2007)12

50% of endoscopic procedure claims are for Cardiopulmonary complications related to endoscopic sedation (Gastrointest’Endosc 2003)13

1:500 of all medical litigation claims in US is related to GI sedation

50% of all sedation complications deemed to have been preventable in anesthesia monitored care situations

• Legal Liability: failure to sedate to standard of care or obtain informed consent.With litigation, even if Anesthesiology present, endoscopist often co-defendant.

Driving after GI Endoscopy

With driving simulators it can take up to 24 hours for some patients after sedation to drive safely (Anesthesiology 2005)14

CAS, AAGB, ADSC, CMPA ---- No driving for 24 hours after sedation ( Anesthesia and Analgesia 2008 )15 This may change in the future.

0.2% patients present without an escort, 55% of those initially claiming they have one. ( Can J Anesth 2005)16 Rate 31% in 1972. (BMJ 1972)17

11% Anesthetists willing to anesthetize without an escort Contrary to all professional guidelines ie ASA, CAS, AAGB, ADSC (Can J Anesth 2004)18

4% patients non compliant with written instructions and drive within 24 hours. (Anaesthesia 2002) Rate 73% in 1972. (BMJ 1972) 17

Informed Consent with endoscopic sedation. Are we doing it?

AGA Institute Review of Endoscopic Sedation 2007 12

Document post-procedure risks with driving, operating heavy equipment, consuming alcohol, and exercising vigorously

Document advice to avoid significant decision making for 24 hours

Document discussion of limitations of sedation regarding pain relief

Document discussion of risks of Cardiopulmonary depression

Document risk of allergic reactions

•Document discussion of endoscopist’s experience with sedation and option of anesthesia to deliver propofol if used, or option of sedation free endoscopy

•One page document recommended and consent obtained by endoscopist

Pre-procedure Assessment and Medical History

Significant cardiac or pulmonary disease

Neurologic or seizure disorder

Stridor, snoring or sleep apnoea

Current medications

Drug, Food allergies, Reactions to prior sedation

• Last oral intake ( 2 hours for clear fluids + 6 hours for light meal -ASA

Guidelines) ?Split Preps (Gastrointestinal Endosc 2010)7

Pregnancy status

Focused Physical Examination prior to Endoscopy

Vital signs and weight

Auscultation of heart and lungs

Baseline level of consciousness

Airway assessment: Difficult airway implies difficulty with intubation and often

difficulty with bag mask ventilation. Difficult airways are often seen with obesity, short necks, cervical spine disease, structural abnormalities of the mouth, jaw and oral cavity.

Time Outs: Patient Name, Consent signed, Proposed procedure, Allergies, Any anticoagulants, Any appliances ( Dentures, Implantable defibrillators, pacemakers etc), Pregnancy status.

Guidelines for Monitoring during GI Endoscopy ( ASGE 2003 )13

Monitor and record Pulse, BP, RR, O2 sat, pre, intra and post procedure

EKG in high risk groups (Vasovagal reactions 16% colonoscopies Gastro Endosc

1993)5

End tidal capnography for high risk groups, lengthy procedures eg ERCP or EUS, or where airway access limited - routine use not proven beneficial

BIS ( bispectral) monitoring -100 fully awake - 0 no brain wave activity 80 ideal for conscious sedation. Correlates well with MOAA/S. Currently research tool

Close clinical monitoring encouraged but capnography clearly superior in detecting hypoventilation/apnoea well before changes noted by observer or with oximetry. Lack data to show oximetry reduces complications ( Gastrointest Endoscopy 2008 ASGE Guidelines)6

Resuscitation equipment /medications/suction immediately available

Emergency Resuscitative Equipment

Dedicated patient suction with tonsil tip suction catheter

Various size Non Rebreathe masks

Ambu Bag with assorted face-masks, oral and nasal airways

Laryngoscope with variety of blades, + assorted ET tubes + stylets

Cardiac Defibrillator

• Emergency Medications: Ephedrine, Naloxone, Flumazenil, Atropine,

Epinephrine, Glucose 50%, Diphenhydramine, Lidocaine, Hydrocortisone, Sodium Bicarbonate, Propofol, and Succinylcholine

Unsedated Endoscopy

56% in Asia

44% Europe

28% Americas, (2% of 20 million endoscopies in North America)

FACTORS

Male Sex, Older Age, Minimal pre procedure anxiety, No abdominal Pain.

• Use of ultra thin endoscopes < 6mm (Gastrointestinal Endoscopy 2006) 1

Water instead of Air for Colonoscopies, 200cc/min 38C

Topical pharyngeal anesthesia

Benefits of Sedation Free Endoscopy

Less hypoxia

Less respiratory depression

Decreased recovery time

Quicker return to work

Allow patients a choice

Decreases risk of Cardiopulmonary complications

Less expensive

Downside of Sedation Free Endoscopy

Less acceptance in North America < 2%

Not as well tolerated compared to use of Sedation Procedure- related abdominal discomfort in patients undergoing colorectal cancer screening: a comparison of colonoscopy and flexible sigmoidoscopy. (Am J Gastroenterol 2002) 2

Concern with follow up/ future endoscopies

Risk of litigation if excessive pain

Goals of Sedation in Endoscopy

Relieve patient anxiety and discomfort

Improve outcome/quality of endoscopic examination

Diminish patient’s memory of the event

Do all the above as safely and economically as possible

Facilitate future patient acceptance of repeat examination

Avoid complaints/litigation due to poor pain control

Improve reputation of endoscopy programme

Levels of sedation

Minimal ( anxiolysis)

Moderate ( conscious ) - usually maintain airway and ventilation

Deep - may lose and not protect airway, may be apnoeic

General Anesthesia - can’t protect airway, often apnoeic and may lose airway

All four levels can occur during endoscopy on same patient

“Deep Sedation occurs frequently during elective endoscopy with meperidine and midazolam” (Patel et al Am J Gastroenterology 2005) 3

Standard meperidine/midazolam doses

MOAA/S scale to measure sedation every 3 minutes ( Modified Observers Assessment of Alertness/Sedation)

68% of all patients had some episodes of deep sedation

26% of all assessments for EGD showed deep sedation

•11% for colonoscopy

•35% ERCP, 29% EUS

“Endoscopists need the skills to resuscitate or rescue a patient whose level of sedation is deeper than planned”. Gastroenterology 2007

(AGA Institute Review of Endoscopic Sedation) 4

What would the perfect sedation medication look like?

Great amnesic, great analgesic, immediate onset of easily titratable sedative action, quick recovery with no hangover effects, no respiratory depression, maintains hemodynamic stability, minimal allergic potential, cheap, and airway compromise not an issue.

Does this medication presently exist? Unfortunately NO

Alternative agents to benzodiazepine/narcotic sedatives: Propofol, Fospropofol, Ketamine, Ketofol, Dexmedetomidine, Promethazine, Droperidol, Diphenhydramine.

Does high quality sedation increase the quality of an endoscopy ie polyp detection rates, cecal intubation? Studies still needed (Endoscopy 2007) 25

Can one predict difficult to sedate Patients? ( ? 25- 30% of all cases)

ASA class IV or V patients

Previous poor quality sedation or adverse reactions to sedation (eg, disinhibited reactions to benzodiazepines)

Chronic alcohol, prescription/psychoactive drug use, or substance abuse

Emergency endoscopic procedures

Complex procedures ie ERCP/Endoscopic ultrasound/FB removals/Stents

• Obese patients ( Turning, risk of airway problems, sharing airway)

Consider using propofol or anesthesia assistance in these cases Average US anesthesia fee for GI sedation is $400 (Dig Dis Sciences July 2010) 19

Who Uses Propofol?

25% US Gastroenterologists ( 7.7% alone) (Cohen et al Am J

Gastroenterol 2006)20

68% not using it, wanted to use it (Cohen et al Am J Gastroenterol 2006)20

>50% Swiss Gastroenterologists

>70% German Endoscopists

• In 2008 only a few interested practitioners in Canada but dramatic increase expected over next decade*

*(Propofol use for sedation during endoscopy in adults: A Canadian Association of Gastroenterology position statement 2008) 21

Why use propofol in GI Endoscopy? Gastrointestinal Endoscopy 2008* 24

Capable of producing Deep Sedation or General anesthesia rapidly*

Patients waken rapidly with quicker recovery and discharge times*

Higher endoscopist satisfaction with quality of sedation*

Patient satisfaction equal to or slightly better than traditional sedative agents*

Complication rate similar or better in average risk patients compared to traditional sedation*

• Improved quality of endoscopy (Meining et al Gastrointest Endosc 2006) 25

Need further studies comparing endoscopist Vs anesthetist delivered propofol for endoscopies.(Nayar et al Dig Dis Sci 2010) 26

Properties of Propofol to consider in GI Endoscopy

Onset of action 30-60 seconds (Induction agent for General Anesthesia)

Duration of effect 4-8 minutes (Half life 2-4 minutes)

No significant pharmacokinetic changes in renal or hepatic disease

Excellent amnesic properties (Similar to midazolam)

•Potentiates narcotics and benzodiazepines but no analgesic properties.

No reversal agent (Time!) Consider ephedrine/neosynephrine for hypotension

Narrow therapeutic window (Big OOPS factor) Decreases cardiac output,

systemic vascular resistance and blood pressure. Reduce dosage in elderly and those with cardiac dysfunction. Mild hypotension common but ? clinical significance (Gastroenterology 2005) 22

Recommendations for Propofol use during Endoscopy (ASGE Guidelines: Sedation and anesthesia in GI endoscopy 2007) 13

Presence of person with ACLS training in room

Trained person with uninterrupted role to monitor patient

Monitoring: Pulse Oximetry, EKG, NIBP. Consider capnography. Physical

observation of patient vital.

• Presence of person capable of airway manoeuvres, bag/mask ventilation

Are these guidelines reasonable? ( Kulling et al Gastro’ Endosc’ 2007) 23

1 physician, 1 nurse, > 27,000 endoscopies, only pulse oximetry and clinical observation. 2.3% hypoxia, 1/5,000 bag mask ventilation, zero deaths, zero hospitalizations related to sedation. Propofol as single agent prospective study

How Propofol is used in GI Endoscopy

How Propofol is used in GI Endoscopy

As sole agent:

a/ Nurse/Anesthetist sole responsibility for propofol delivery

b/ Nurse gives propofol under direction of endoscopist

• As Balanced Sedation combined with Narcotic +/- Benzodiazepine

a/ Nurse/ Anesthetist sole responsibility for all sedation

b/ Nurse gives sedation including propofol under direction of endoscopist

c/ Patient controlled analgesia (PCA) pumps, Computer assisted personalized sedation ( CAPS ) infusions ( Sedasys ), TCI (Target controlled Infusions)

Is there a best way to use Propofol in GI endoscopy?

Is propofol monotherapy the pinnacle of endoscopic sedation? (Probably not)

Propofol monotherapy had higher doses and deeper sedation scores, and delayed discharge compared to combination therapy. (Gastrointestinal Endoscopy 2007) 27

Balanced propofol involves combinations of benzodiazepine, narcotic and incremental doses of propofol.

Balanced usage combines best assets of each class and small boluses of propofol give deeper short lived sedation if and when needed. Allows flexibility and reversal agents available. Easier to use without anesthesia providers being present.

Titration is vital and Propofol usage probably more demanding than narcotic benzodiazepine combinations (Gastroenterology 2002) 28

Barriers to Propofol use in GI endoscopy

Nursing Organizations

Licensing Boards ( CPSA )

FDA approved drug labelling

Privileging

Access to training in Propofol usage

Inter Medical specialty politics and economics

Cost of propofol

Training Guidelines for Propofol Usage in GI Endoscopy

Didactic Training session

Airway Workshop

Simulation Training

Perceptorship

Current lack of standardized training in GI sedation during and after residency for GI specialists and other endoscopists. ASGE since 2010 offering annual sedation and monitoring courses for endoscopists and endoscopy nurses.

Future goals? To create a local CPSA approved training/perceptorship program to facilitate endoscopists to use Propofol safely here in Alberta and elsewhere.

Conscious Sedation Memphis November 2011 Journal References

1/ “ Unsedated ultrathin EGD by using a 5.2 mm- diameter videoscope: an evaluation of acceptability and diagnostic accuracy” Horiuchi A et al. Gastrointestinal Endoscopy 2006; 64: 868-873

2/ “Procedure-related abdominal discomfort in patients undergoing colorectal cancer screening: a comparison of colonoscopy and flexible sigmoidoscopy”Zubarik et al. Am J Gastroenterology 2002 Dec; 97 (12): 3056-61

3/ “ Deep sedation occurs frequently during elective endoscopy with meperidine and midazolam”Patel S et al. Am J Gastrolenterology 2005 Dec; 100 (12): 2689-95

4/ “ AGA Institute Review of Endoscopic Sedation”Lawrence B. Cohen et al. Gastroenterology 2007; 133: 675-701 5/ “ Risk factors associated with vasovagal reactions during colonoscopy””Hermann LL et al. Gastrointestinal Endoscopy 1993; 39: 388-91

6/ “ Sedation and anesthesia in GI endoscopy” David R. Lichtenstein et al. Gastrointestinal Endoscopy 2008; 68, No.5 815-826

7/ “ Split-dose bowel preparation for colonoscopy and residual gastric fluid volume: an observational study”Huffman M et al. Gastrointestinal Endoscopy 2010 Sep; 72 (3) : Epub 2010 Jun 19

8/ “ A national study of cardiopulmonary unplanned events after GI endoscopy” Virender K. Sharma et al. Gastrointestinal Endoscopy 2007 Volume 66, No. 1: 27-34

9/ “ Results from the American Society for Gastrointestinal Endoscopy/U.S. Food and Drug collaborative study on complication rates and drug use during gastrointestinal endoscopy” Arrowsmith JB et al. Gastrointestinal Endoscopy 1991; 37: 421-7

10/ “ Closed claims review of anesthesia for procedures outside the operating room” Robbertze R et al. Current Opinions in Anesthesiology 2006; 19: 436-442

11/ “Effect of blood pressure instrument and cuff size on blood pressure reading in pregnant women in the lateral recumbent position” Kinsella Sm Int J Obstet Anesth 2006 Oct; 15 (4): 290-3 Epub 2006 Sep 1

11a/ “ Reporting of ‘ hypotension’ after epidural analgesia during labour. Effect of choice of arm and timing of baseline readings. Kinsella SM et al. Anaesthesia 1998 Feb; 53(2): 131-135

Conscious Sedation Memphis November 2011 Journal References

12/ “ AGA Institute Review of Endoscopic Sedation” Lawrence B. Cohen Gastroenterology 2007: 133: 675-701

13/ “ Guidelines for conscious sedation and monitoring during gastrointestinal endoscopy” (ASGE) J.Patrick Waring et al. Gastrointestinal Endoscopy 2003 Vol 58; No.3: 317-22

14/ “ What is the driving performance of ambulatory surgical patients after general anesthesia? Chung F et al. Anesthesiology 2005; 103: 951-6

15/ “ Car Accidents After Ambulatory Surgery in Patients Without an Escort” Frances Chung et al. Anesthesia and Analgesia 2008 Vol 106; No. 3: 817-820

16/ “ Frequency and implications of ambulatory surgery without a patient escort” Chung F et al. Can J Anaesth 2005; 52: 1022-6

17/ “ An assessment of postoperative outpatient cases” Ogg TW. BMJ 1972; 4: 573-6

18/ “ Ambulatory surgery adult patient selection criteria-a survey of Canadian anesthesiologists. Friedman Z et al. Can J Anaesth 2004; 51: No. 5, 437-443

19/ “ Redefining Quality in Endoscopic Sedation” Lawrence B. Cohen Dig Dis Sci 2010; 55: 2425-2427

20/ “ Endoscopic sedation in the United States: results from a nationwide survey” Cohen LB. Am J Gastroenterology 2006 May1st; 101(5): 967-974

21/ “ Propofol Use for sedation during endoscopy in adults: A Canadian Association of Gastroenterology position statement” Michael Byrne et al. Can J Gastroenterology 2008; Vol. 22 No.5 : 457-459

22/ “ Trained registered nurses/endoscopy teams can administer propofol safely for endoscopy” Rex DK et al. Gastroenterology 2005; 129: 1384-1391

23/ “ Propofol sedation during endoscopic procedures: how much staff and monitoring are necessary? Daniel Kulling et al. Gastrointestinal Endoscopy 2007; Vol 66: No. 3: 443- 449

Conscious Sedation Memphis November 2011 Journal References

24/ “ A systemic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures” McQuaid et al. Gastrointest Endosco’ 2008; 67: 910-23

25/ “ The effect of sedation on the quality of upper gastrointestinal endoscopy: an investigator blinded randomized study comparing propofol with midazolam” Meining A. et al. Endoscopy 2007; 39: 345-349

26/ “ Comparison of propofol deep sedation versus moderate sedation during endosonography” Nayar DS et al. Dig Dis Sci 2010 55: 2537-2544

27/ “ Big NAPS, little NAPS, mixed NAPS, computerized NAPS: what is your flavor of propofol?” Vargo John J. Gastrointestinal Endoscopy 2007; Vol 66, No.3: 457-459

28/ “Gastroenterologist-administered propofol versus merperidine and midazolam for advanced upper endoscopy: a prospective randomized trial” Vargo JJ et al. Gastroenterology 2002; 123: 8-16

29/ Endoscopist-directed administration of Propofol: a world-wide safety experience. Rex, DK. Gastroenterology Oct 2009; 137(4): 1229-1237