Year 2018 / Volume 110 / Number 11
Original
A clinical trial comparing propofol versus propofol plus midazolam in diagnostic endoscopy of patients with a low anesthetic risk

691-698

DOI: 10.17235/reed.2018.5289/2017

Laura Julián Gómez, Ana Fuentes Coronel, Carmen López Ramos, Carlos Ochoa Sangrador, Paola Fradejas Salazar, Eva Martín Garrido, Pilar Conde Gacho, Carmen Bailador Andrés, María García-Alvarado, Gabriella Rascarachi, Rocio Castillo Trujillo, Santiago José Rodríguez Gómez,

Abstract
Background and objectives: propofol and midazolam are two of the most commonly used sedatives in upper gastrointestinal endoscopy (UGE). The objective of this study was to evaluate these two sedation regimens administered to patients who underwent an UGE with regard to security, efficiency, quality of exploration and patient response. Patients and methods: a prospective, randomized and double-blind study was performed which included 83 patients between 18 and 80 years of age of a low anesthetic risk (ASA - American Society of Anesthesiologists- I-II) who underwent a diagnostic UGE. Patients were randomized to receive sedation with either placebo plus propofol (group A) or midazolam plus propofol (group B). Results: in group A, 42 patients received a placebo bolus (saline solution) and on average up to 115 mg of propofol in boluses of 20 mg. In group B, 41 patients received 3 mg of midazolam and an average of up to 83 mg of propofol in boluses of 20 mg. There were no significant differences in the adverse effects observed in either group and all adverse events were treated conservatively. The patients in group B (midazolam plus propofol) entered the desired sedated state more quickly with no variation in the overall time of the exploration. The quality of the endoscopic evaluation was similar in both groups and the patients were equally satisfied regardless of the sedatives they received. Conclusions: the use of midazolam plus propofol as a sedative does not affect the overall exploration time, a lower dose of propofol can be used and it is as safe as administering propofol as a monotherapy while providing the same level of both exploration quality and patient approval.
Share Button
New comment
Comments

13/11/2020 20:49:57
muy bueno


References
1. Igea F, Casellas JA, Gonzalez-Huix F, et al. Sedation for gastrointestinal endoscopy. Clinical practice guidelines of the Sociedad Española de Endoscopia Digestiva. Rev Esp Enferm Dig 2014;106:195-211.
2. Dumonceau JM, Riphaus A, Aparicio JR et al. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: non-anaesthesiologist administration of propofol for GI endoscopy. Eu J Anaesthesiol 2010;27:1016-30.
3. Lazzaroni M, Bianchi-Porro G. Premedication, preparation, and surveillance. Endoscopy 1999;31:2-8
4. Froehlich F, Gonvers JJ, Fried M. Conscious sedation, clinically relevant complications and monitoring of endoscopy: results of a nationwide survey in Switzerland. Endoscopy 1994;26:231-234.
5. Tohda G, Higashi S, Wakahara S et al. Propofol sedation during endoscopic procedures: safe and effective administration by registered nurses supervised by endoscopists. Endoscopy 2006;38:360-367.
6. Saenz-Lopez S, Rodriguez Muñoz S, Rodriguez-Alcalde D, et al. Endoscopist controlled administration of propofol: an effective and safe method of sedation in endoscopic procedures. Rev Esp Enferm Dig 2006;98:25-35.
7. Sipe BW, Scheidler M, Baluyut A et al. A prospective safety study of a low-dose propofol sedation protocol for colonoscopy. Clin Gastroenterol Hepatol 2007;5:563-566.
8. Martínez J, Casellas JA, Aparicio JR et al. Safety of propofol administration by the staff of a gastrointestinal endoscopy unit Gastroenterol Hepatol 2007;30(3):105-9
9. Morse JW, Fowler SA, Morse AL. Endoscopist-administered propofol: a retrospective safety study. Can J Gastroenterol 2008;22:617-620.
10. Lucendo AJ, Olveira A, Friginal-Ruiz AB et al. Nonanesthesiologist-administered propofol sedation for colonoscopy is safe and effective: a prospective Spanish study over 1000 consecutive exams. Eur J of Gastroenterol and Hepatol 2012;24(7):787-92.
11. Friedrich K, Stremmel W, Sieg A. Endoscopist-administered propofol sedation is safe a prospective evaluation of 10,000 patients in an outpatient practice. J Gastrointestin Liver Dis 2012 Sep;21(3):259-63.
12. Sieg A, Beck S, Scholl SG et al. Safety analysis of endoscopist-directed propofol sedation: A prospective, national multicenter study of 24441 patients in German outpatient practices. J Gastroenterol Hepatol 2014;29:517-23.
13. Meining A, Semmler V, Kassem AM, et al. The effect of sedation on the quality of upper gastrointestinal endoscopy: an investigator-blinded, randomized study comparing propofol with midazolam. Endoscopy 2007;39(4):345-9
14. Chernik DA, Gillings D, Laine H et al. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol 1990 Aug;10(4):244-51.
15. Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth 1995;7:89-91.
16. Lightdale JR, Valim C, Newburg AR et al. Efficiency of propofol versus midazolam and fentanyl sedation at a pediatric teaching hospital: a prospective study. Gastrointest Endosc. 2008;67:1067–1075.
17. Thornley P, Al Beshir M, Gregor J et al. Efficiency and patient experience with propofol vs conventional sedation: A prospective study. World J Gastrointest Endosc. 2016;8(4):232-8.
18. Vargo JJ, Zuccaro G, Dumot JA et al. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology 2002;123:8–16
19. Qadeer MA, Vargo JJ, Khandwala F et al. Propofol versus traditional sedative agents for gastrointestinal endoscopy: a meta-analysis. Clin Gastroenterol Hepatol 2005;3:1049-1056
20. Sethi S, Wadhwa V, Thaker A et al. Propofol versus traditional sedative agents for advanced endoscopic procedures: a meta-analysis. Dig Endosc 2014;26:515–524.
21. Wehrmann T, Kokabpick S, Lembcke B et al Eficacy and safety of intravenous propofol sedation during routine ERCP. A prospective, controlled study. Gastrointest Endosc 1999;49:677-83.
22. Scott RPF, Saunders DA, Norman J. Propofol: clinical strategies for preventing the pain of injection. Anaesthesia 1988;43:492-4.
23. Hofmann C, Kiesslich R, Brackertz A et al. Propofol for sedation in gastroscopy--a randomized comparison with midazolam. Z Gastroenterol 1999;37(7):589-95.
24. Eun Hye Kim, Sang Kil Lee. Endoscopist-Directed Propofol: Pros and Cons. Clinical Endoscopy 2014;47:129-134
25. Short TG, Chui PT. Propofol and midazolam act synergistically in combination. Br J Anaesth 1991;67:539-45.
26. McClune S, McKay AC, Wright PMC et al. Synergistic interaction between midazolam and propofol. Br J Anaesth 1992;69:240-5.
27. Levitzky BE, Lopez R, Dumot JA et al. Moderate sedation for elective upper endoscopy with balanced propofol versus fentanyl and midazolam alone: a randomized clinical trial. Endoscopy 2012;44:13-20.
28. Repici A, Pagano N, Hassan C et al. Balanced propofol sedation administered by nonanesthesiologists: the first Italian experience. World J Gastroenterol 2011;17:3818-23.
29. VanNatta ME, Rex DK. Propofol alone titrated to deep sedation versus propofol in combination with opioids and/or benzodiazepines and titrated to moderate sedation for colonoscopy. Am J Gastroenterol 2006;101:2209-2217
30. Molina-Infante J, Dueñas-Sadornil C, Mateos-Rodriguez JM et al. Nonanesthesiologist-administered propofol versus midazolam and propofol, titrated to moderate sedation, for colonoscopy: a randomized controlled trial. Dig Dis Sci 2012;57(9):2385-93.
31. Seifert H, Schmitt TH, Gultekin T et al. Sedation with propofol plus midazolam versus propofol alone for interventional endoscopic procedures: a prospective, randomized study. Aliment Pharmacol Ther 2000;14:1207-14.
32. Chun SY, Kim KO, Park DS et al. Safety and Efficacy of Deep Sedation with Propofol Alone or Combined with Midazolam Administrated by Nonanesthesiologist for Gastric Endoscopic Submucosal Dissection. Gut Liver 2012;6: 464-470.
33. Lee TH, Lee CK, Park SH et al. Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures. Dig Dis Sci 2012;57:2113–21.
34. Sipe BW, Rex DK, Latinovich D et al. Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists. Gastrointest Endosc 2002;55:815-825.
35. Külling D, Rothenbühler R, Inauen W. Safety of nonanesthetist sedation with propofol for outpatient colonoscopy and esophagogastroduodenoscopy. Endoscopy. 2003 Aug;35(8):679-82.
36. Cohen LB, Hightower CD, Wood DA et al. Moderate level sedation during endoscopy:
a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc 2004;59:795-803.
37. Loftus R, Nugent Z, Graff LA et al. Patient satisfaction with the endoscopy experience and willingness to return in a central Canadian health region. Can J Gastroenterol. 2013;27:259-266.
38. Ko HH, Zhang H, Telford JJ et al. Factors influencing patient satisfaction when undergoing endoscopic procedures. Gastrointest Endosc 2009;69:883-891.
39. Lin OS, Schembre DB, Ayub K et al. Patient satisfaction scores for endoscopic procedures: impact of a survey-collection method. Gastrointest Endosc 2007;65:775-781.
Related articles

Digestive Diseases Image

A case of duodenal-type follicular lymphoma

DOI: 10.17235/reed.2021.8233/2021

Letter

Basic training in gastrointestinal endoscopy: recording images

DOI: 10.17235/reed.2020.7385/2020

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

Digestive Diseases Image

Dysphagia and hematemesis caused by an intramural esophageal dissection

DOI: 10.17235/reed.2018.5471/2018

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
Julián Gómez L, Fuentes Coronel A, López Ramos C, Ochoa Sangrador C, Fradejas Salazar P, Martín Garrido E, et all. A clinical trial comparing propofol versus propofol plus midazolam in diagnostic endoscopy of patients with a low anesthetic risk. 5289/2017


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 1324 visits.
This article has been downloaded 351 times.

Statistics from Dimensions


Statistics from Plum Analytics

Publication history

Received: 30/09/2017

Accepted: 19/03/2018

Online First: 15/10/2018

Published: 30/10/2018

Article revision time: 164 days

Article Online First time: 380 days

Article editing time: 395 days


Share
This article has been rated by 1 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 2023 y Creative Commons. The Spanish Journal of Gastroenterology