Year 2017 / Volume 109 / Number 2
Special Article
Patient safety under deep sedation for digestive endoscopic procedures

137-143

DOI: 10.17235/reed.2016.4572/2016

Julián Álvarez, Rafael Cabadas, Manuel de la Matta,

Abstract
Deep sedation with Propofol has become popular in recent years. The safety of this technique when administered by non-anaesthesiologists has created much controversy which at times is masked in a contentious debate on the economic sustainability of the health system. In 2011, the Spanish Society of Anaesthesiology, Resuscitation and Pain Therapy, along with 20 other organisations from European countries, revoked the recommendations of the European Society of Gastrointestinal Endoscopy on the administration of Propofol by non-anaesthesiologists, citing that it is "extremely dangerous for the safety and quality of endoscopic procedures". The FDA in 2005 had already rejected the use of Propofol by non-anaesthesiologists in the United States, a prohibition which was reiterated in 2010 and is still in force, basing its evidence, among others, on the recommendations and guidelines of the Joint Commission and the Declaration of Helsinki. In Spain, the data sheet of Propofol restricts the use of the drug to anaesthesiologists and intensivists in intensive care units. In our opinion, the key elements to discuss (which we develop in our paper) are those related to: a) the morbidity and mortality of sedation (which is the same as speaking about the factors that influence its safety); b) the appropriate professionals to use this technique; and c) economic aspects related to the use of said technique. Our conclusion is that a technique cannot be declared safe when a high percentage of patients present with varying respiratory depression (and therefore hypoxaemia) and hypotension. We are confident that the collaboration of the Spanish Society of Digestive Pathology and the Spanish Society of Digestive Endoscopy with the Spanish Society of Anaesthesiology, Resuscitation and Pain Therapy is the first step towards finding a satisfactory solution for everyone, and especially for our patients.
Share Button
New comment
Comments
No comments for this article
References
1. Rex DK, Heuss LT, Walker JA, Qi R. Trained registered nurses/endoscopy teams can administer propofol safely for endoscopy. Gastroenterology. 2005;129:1384-91.
2. Tohda G, Higashi S, Wakahara S, Morikawa M, Sakumoto H, Kane T. Propofol sedation during endoscopic procedures: Safe and effective administration by registered nurses supervised by endoscopists. Endoscopy. 2006;38:360-7
3. Cohen LB, Ladas SD, Vargo JJ, Paspatis GA, Bjorkman DJ, Van der Linden P, Axon AT, Axon AE, Bamias G, Despott E, Dinis-Ribeiro M, Fassoulaki A, Hofmann N, Karagiannis JA, Karamanolis D, Maurer W, O'Connor A, Paraskeva K, Schreiber F, Triantafyllou K, Viazis N, Vlachogiannakos J. Sedation in digestive endoscopy: the Athens international position statements. Aliment Pharmacol Ther 2010; 32: 425-42.
4. Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, et al; NAAP Task Force Members. European Society of Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology. Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010; 42: 960-74. doi: 10.1055/s-0030-1255728
5. Perel A. Non-anaesthesiologists should not be allowed to administer propofol for procedural sedation: a Consensus Statement of 21 European National Societies of Anaesthesia Eur J Anaesthesiol. 2011; 28: 580-4. doi: 10.1097/EJA.0b013e328348a977
6. Riphaus A. Endoscopy: consensus on approving propofol sedation by nonanesthesiologists. Nat Rev Gastroenterol Hepatol. 2010; 7: 187-8.
7. Porostocky P, Chiba N, Colacino P, Sadowski D, Singh h. A survey of sedation practices for colonoscopy in Canada. Can J Gastroenterol 2011; 25: 255-60.
8. Agostoni M, Fanti L, Gemma M, Pasculli N, Beretta L, Testoni PA. Adverse events during monitored anesthesia care for GI endoscopy: an 8-year experience. Gastrointest Endoscop 2011 ;74: 266-75.
9. Bo LL, Bai Y, Bian JJ, et al. Propofol vs traditional sedative agents for endoscopic retrograde cholangiopancreatography: A meta-analysis. World J Gastroenterol 2011; 17: 3538-43.
10. De Witt J, McGreevy K, Sherman S, et al. Nurse-administered propofol sedation compared with midazolam and meperidine for EUS: a prospective, randomized trial. Gastrointest Endosc 2008;68:499-509. DOI: 10.1016/j.gie.2008.02.092
11. Riphaus A, Geist F, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: re-evaluation from the first nationwide survey 3 years after the implementation of an evidence and consent based national guideline. Z Gastroenterol. 2013; 51: 1082-8.
12. Cooper GS, Kou TD, Rex DK. Complications following colonoscopy with anesthesia assistance: a population-based analysis. JAMA Intern Med 2013; 173 551-6.
13. Garewal D, Waikar P. Propofol Sedation for ERCP Procedures: A Dilemna? Observations from an Anesthesia Perspective. Diagn Ther Endosc. 2012; 2012:639190. doi: 10.1155/2012/639190. Epub 2012 Jan 5.
14. Adeyemo A, Bannazadeh M, Riggs T, Shellnut J, Barkel D, Wasvary H. Does sedation type affect colonoscopy perforation rates? Dis Colon Rectum 2014; 57: 110-4. doi: 10.1097/DCR.0000000000000002
15. Briz Sáenz J, Aguilera Celorrio L, Gilsanz Rodríguez F. Los anestesiólogos somos los garantes de la seguridad y calidad en las salas de endoscopia. Rev Esp Anestesiol Reanim. 2015; 62: 425-7.
16. Hagan KB, Thirumurthi S, Gottumukkala R, Vargo J. Sedation in the Endoscopy Suite. Curr Treat Options Gastroenterol. 2016; 14: 194-209
17. Vargo JJ, Niklewski PJ, Williams JL, Martin JF, Faigel DO. Patient safety during sedation by anesthesia profesionals during routine upper endoscopy and colonoscopy: an analysis of 1,38 million procedures. Gastrointest Endosc 2016. DOI: 10.1016/j.gie.2016.02.007
18. González-Huix Lladó F. Sedación en endoscopia en el año 2016: ¿es segura la sedación con propofol dirigida por el endoscopista en situaciones complejas?. Rev Esp Enferm Dig 2016; 108: 237-9. doi: 10.17235/reed.2016.4383/2016
19. Wernli KJ, Brenner AT, Rutter CM, Inadomi JM. Risk associated with anesthesia services during colonoscopy. Gastroenterology. 2016; 150: 888-94.
20. Pérez-Cuadrado Robles E, González Ramírez A, Lancho Seco Á, Martí Marqués E, Dacal Rivas A, Castro Ortiz E, González Soler R, Álvarez Suárez B, Tardáguila García D, López Baz A, Fernández López A, López Roses L.. Safety and risk factors for difficult endoscopist-directed ERCP sedation in daily practice: a hospital-based case-control study. Rev Esp Enferm Dig 2016; 108:240-5.
21. FDA. FDA/CDER to Williams & Connolly LLP (American College of Gastroenterology) - Petition Denial. June 27, 2005. Document ID FDA-2005-P-0059-0080. Url: http://digestivehealth.net/images/FDA-2005-P-0059-0080_1_.pdf
22. Vargo J. Update on Endoscopist-Administered Propofol Sedation for Endoscopic Procedures. Gastroenterol Hepatol (N Y). 2011 Mar; 7(3): 189–197. PMCID: PMC3079150
23. http://www.jointcommissioninternational.org/assets/3/7/Hospital-5E-Standards-Only-Mar2014.pdf
24. Mellin-Olsen J, Pelosi P, Van Aken H. Declaración de Helsinki sobre la seguridad de los pacientes en Anestesiología. Rev Esp Anestesiol Reanim. 2010;57:594-5.
25. 25. Ficha técnica propofol. Disponible en: http://www.aemps.gob.es/cima/pdfs/es/ft/61297/FT_61297.pdf
26. Wehrmann T, Riphaus A. Sedation with propofol for interventional endoscopic procedures: a risk factor analysis. Scand J Gastroenterol. 2008; 43: 368-74.
27. Tohda G, Higashi S, Wakahara S, Morikawa M, Sakumoto H, Kane T. Propofol sedation during endoscopic procedures: safe and effective administration by registered nurses supervised by endoscopists. Endoscopy. 2006; 38:360–367
28. Fatima H, DeWitt J, LeBlanc J, Sherman S, McGreevy K, Imperiale TF. Nurse-administered propofol sedation for upper endoscopic ultrasonography. Am J Gastroenterol. 2008; 103: 1649-56.
29. Horiuchi A, Nakayama Y, Hidaka N, Ichise Y, Kajiyama M, Tanaka N. Low-dose propofol sedation for diagnostic esophagogastroduodenoscopy: results in 10,662 adults. Am J Gastroenterol. 2009; 104: 1650-5.
30. Schilling D, Rosenbaum A, Schweizer S, Richter H, Rumstadt B. Sedation with propofol for interventional endoscopy by trained nurses in high-risk octogenarians: a prospective, randomized, controlled study. Endoscopy. 2009; 41: 295-8.
31. Coté GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010; 8: 137-42
32. Slagelse C, Vilmann P, Hornslet P, Hammering A, Mantoni T. Nurse-administered propofol sedation for gastrointestinal endoscopic procedures: first Nordic results from implementation of a structured training program. Scand J Gastroenterol. 2011; 46: 1503-9.
33. Jensen JT, Vilmann P, Horsted T, Hornslet P, Bodtger U, Banning A, Hammering A. Nurse-administered propofol sedation for endoscopy: a risk analysis during an implementation phase. Endoscopy. 2011; 43: 716-22.
34. Redondo-Cerezo E, Sánchez-Robaina A, Martínez Cara JG, Ojeda-Hinojosa M, Matas-Cobos A, Sánchez Capilla AD, López de Hierro Ruíz M, Pleguezuelo-Díaz J, de Teresa J. Gastroenterologist-guided sedation with propofol for endoscopic ultrasonography in average-risk and high-risk patients: a prospective series. Eur J Gastroenterol Hepatol. 2012; 24: 506-12
35. Pambianco DJ, Vargo JJ, Pruitt RE, Hardi R, Martin JF. Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study. Gastrointest Endosc. 2011; 73: 765-72.
36. Thornley P, Al Beshir MA, Gregor J, Antoniou A, Khanna N. Efficiency and patient experience with propofol vs conventional sedation: A prospective study. World J Gastroenterol 2016; 8: 232-8. doi: 10.4253/wjge.v8.i4.232.
37. Inadomi JM, Gunnarsson CL, Rizzo JA, Fang H. Projected increased growth rate of anesthesia professional-delivered sedation for colonoscopy and EGD in the United States: 2009 to 2015. Gastrointest Endosc 2010; 72: 580-6.
38. Birk J, Bath RK. Is the anesthesiologist necessary in the endoscopy suite? A review of patients, payers and safety. Expert Rev Gastroenterol Hepatol 2015;9:883-5.
39. Day LW, Siao D, Inadomi JM, Somsouk M.. Non-Physicians Performing Lower and Upper Endoscopy: A Systematic Review and Meta-Analysis. Endoscopy, 2014; 46: 401-10.
40. Ikenberry SO, Anderson MA, Banerjee S, Baron TH, Dominitz JA, Gan SI, Harrison ME, Jagannath S, Levy M, Lichtenstein D, Shen B, Fanelli RD, Stewart L, Khan K. American Society for Gastrointestinal Endoscopy. Endoscopy by nonphysicians. Gastrointestinal endoscopy 2009; 69: 767-70. doi: 10.1016/j.gie.2008.11.006.
41. Stephens M, Hourigan LF, Appleyard M et al. Non-physician endoscopists: A systematic review. World J Gastroenterol 2015; 21: 5056-71.
42. Spencer RJ, Ready RL. Utilization of nurse endoscopists for sigmoidoscopic examinations. Dis Colon Rectum 1977; 20: 94-6.
43. Massl R, van Putten PG, Steyerberg EW, van Tilburg AJ, Lai JY, de Ridder RJ, Brouwer JT, Verburg RJ, Alderliesten J, Schoon EJ, van Leerdam ME, Kuipers EJ. Comparing quality, safety, and costs of colonoscopies performed by nurse vs physician trainees. Clin Gastroenterol Hepatol 2014; 12: 470-7.
44. Gaba DM. Anaesthesiology as a model for patient safety in healthcare. BMJ. 2000; 320: 785-8.
45. Van Aken H, Staender S, Mellin-Olsen J, Pelosi P. Patient safety in anaesthesiology. Best Pract Res Clin Anaesthesiol. 2011; 25:ix:x doi: 10.1016/j.bpa.2011.02.012
46. Schleppers A, Prien T, Van Aken H. Helsinki Declaration on patient safety in anaesthesiology: putting words into practice - experience in Germany. Best Pract Res Clin Anaesthesiol. 2011 Jun;25(2):291-304. doi: 10.1016/j.bpa.2011.02.011
47. Buxbaum J , Roth N 1 , Motamedi N , Lee T , Leonor P , Salem M , Gibbs D , Vargo J . Anestesista-Directed sedación favores de éxito de los procedimientos endoscópicos avanzada. Am. J. Gastroenterol16 julio 12. doi: 10.1038 / ajg.2016.285.
Related articles

Special Article

Endoscopy and sedation: an inseparable binomial for the gastroenterologist

DOI: 10.17235/reed.2018.5585/2018

Letter to the Editor

Me, the intruder: revisited and rethought

DOI: 10.17235/reed.2018.5575/2018

Letter to the Editor

Propofol sedation Quality and safety. Failure mode and effects analysis.

DOI: 10.17235/reed.2017.4976/2017

Letter to the Editor

Enough discussions about who should use propofol in gastrointestinal endoscopy

DOI: 10.17235/reed.2017.4901/2017

Citation tools
Álvarez J, Cabadas R, de la Matta M. Patient safety under deep sedation for digestive endoscopic procedures . 4572/2016


Download to a citation manager

Download the citation for this article by clicking on one of the following citation managers:

Metrics
This article has received 1141 visits.
This article has been downloaded 512 times.

Statistics from Dimensions


Statistics from Plum Analytics

Publication history

Received: 04/08/2016

Accepted: 16/09/2016

Online First: 22/12/2016

Published: 31/01/2017

Article revision time: 8 days

Article Online First time: 140 days

Article editing time: 180 days


Share
This article has been rated by 33 readers.
Reader rating:
Valora este artículo:




Asociación Española de Ecografía Digestiva Sociedad Española de Endoscopia Digestiva Sociedad Española de Patología Digestiva
The Spanish Journal of Gastroenterology is the official organ of the Sociedad Española de Patología Digestiva, the Sociedad Española de Endoscopia Digestiva and the Asociación Española de Ecografía Digestiva
Cookie policy Privacy Policy Legal Notice © Copyright 2024 y Creative Commons. The Spanish Journal of Gastroenterology