Drug Safety Clinical Trial
— MIDAPROPOfficial title:
Phase 4, Prospective, Randomized, Double-blinded, Placebo-controlled Study Comparing Propofol vs. Midazolam Plus Propofol for Nonanesthesiologist Targeted Moderate Sedation in Outpatient Colonoscopy
Verified date | December 2011 |
Source | Infante, Javier Molina, M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
Nonanesthesiologist administration of propofol for sedation is actually a field of growing
interest for endoscopists, as demonstrated by recent American and European guidelines on
this issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a
single agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation
(BPS), which combines propofol with small doses of a benzodiazepine and/or an opioid, can be
successfully titrated to moderate sedation. However, nonanesthesiologists propofol
administration remains controversial on account of the possibility of deep sedation/general
anesthesia related adverse events. On the other hand, the use of longer elimination
half-life drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and
recovery.
Up to date, no study has addressed a head-to-head comparison of both regimens administered
by non-anesthesiologists and titrated to moderate sedation.
This study aims to evaluate the impact on propofol sedation of premedication with a fixed
dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate
sedation, in terms of depth of sedation, recovery times, safety and satisfaction.
The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak
effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts
a minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam
may increase the depth of sedation through the initial phases of the procedure, diminishing
propofol requirements, but not prolonging significantly recovery times.
Status | Completed |
Enrollment | 135 |
Est. completion date | December 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients undergoing elective outpatient colonoscopy Exclusion Criteria: - Age less than 18 years - Allergy to propofol, soybeans, eggs or midazolam - Chronic intake of benzodiazepines - History of colorectal surgery - ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely - Pregnancy - Refusal, inability or unwillingness to give written consent - Patients scheduled for advanced therapeutic colonoscopy or for more than one endoscopic procedure |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital San Pedro de Alcantara | Caceres |
Lead Sponsor | Collaborator |
---|---|
Infante, Javier Molina, M.D. |
Spain,
Cohen LB, Dubovsky AN, Aisenberg J, Miller KM. Propofol for endoscopic sedation: A protocol for safe and effective administration by the gastroenterologist. Gastrointest Endosc. 2003 Nov;58(5):725-32. — View Citation
Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc. 2004 Jun;59(7):795-803. — View Citation
Cohen LB. Making 1+1=3: improving sedation through drug synergy. Gastrointest Endosc. 2011 Feb;73(2):215-7. doi: 10.1016/j.gie.2010.10.027. — View Citation
Cohen LB. Sedation issues in quality colonoscopy. Gastrointest Endosc Clin N Am. 2010 Oct;20(4):615-27. doi: 10.1016/j.giec.2010.07.003. Epub 2010 Aug 21. Review. — View Citation
Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal 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 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11. — View Citation
Kerker A, Hardt C, Schlief HE, Dumoulin FL. Combined sedation with midazolam/propofol for gastrointestinal endoscopy in elderly patients. BMC Gastroenterol. 2010 Jan 27;10:11. doi: 10.1186/1471-230X-10-11. — View Citation
Lee CK, Lee SH, Chung IK, Lee TH, Park SH, Kim EO, Lee SH, Kim HS, Kim SJ. Balanced propofol sedation for therapeutic GI endoscopic procedures: a prospective, randomized study. Gastrointest Endosc. 2011 Feb;73(2):206-14. doi: 10.1016/j.gie.2010.09.035. Epub 2010 Dec 18. — View Citation
McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008 May;67(6):910-23. doi: 10.1016/j.gie.2007.12.046. Review. — View Citation
Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009 Nov;109(5):1448-55. doi: 10.1213/ane.0b013e3181a6ad31. Epub 2009 Jul 17. — View Citation
Paspatis GA, Manolaraki M, Xirouchakis G, Papanikolaou N, Chlouverakis G, Gritzali A. Synergistic sedation with midazolam and propofol versus midazolam and pethidine in colonoscopies: a prospective, randomized study. Am J Gastroenterol. 2002 Aug;97(8):1963-7. — View Citation
Rex DK, Deenadayalu V, Eid E. Gastroenterologist-directed propofol: an update. Gastrointest Endosc Clin N Am. 2008 Oct;18(4):717-25, ix. doi: 10.1016/j.giec.2008.06.002. Review. — View Citation
Rex DK, Deenadayalu VP, Eid E, Imperiale TF, Walker JA, Sandhu K, Clarke AC, Hillman LC, Horiuchi A, Cohen LB, Heuss LT, Peter S, Beglinger C, Sinnott JA, Welton T, Rofail M, Subei I, Sleven R, Jordan P, Goff J, Gerstenberger PD, Munnings H, Tagle M, Sipe BW, Wehrmann T, Di Palma JA, Occhipinti KE, Barbi E, Riphaus A, Amann ST, Tohda G, McClellan T, Thueson C, Morse J, Meah N. Endoscopist-directed administration of propofol: a worldwide safety experience. Gastroenterology. 2009 Oct;137(4):1229-37; quiz 1518-9. doi: 10.1053/j.gastro.2009.06.042. Epub 2009 Jun 21. Review. — View Citation
Rex DK. Review article: moderate sedation for endoscopy: sedation regimens for non-anaesthesiologists. Aliment Pharmacol Ther. 2006 Jul 15;24(2):163-71. Review. — View Citation
Singh H, Poluha W, Cheung M, Choptain N, Baron KI, Taback SP. Propofol for sedation during colonoscopy. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006268. doi: 10.1002/14651858.CD006268.pub2. Review. — View Citation
Sipe BW, Scheidler M, Baluyut A, Wright B. A prospective safety study of a low-dose propofol sedation protocol for colonoscopy. Clin Gastroenterol Hepatol. 2007 May;5(5):563-6. — View Citation
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 Oct;101(10):2209-17. — View Citation
Vargo JJ, Cohen LB, Rex DK, Kwo PY. Position statement: nonanesthesiologist administration of propofol for GI endoscopy. Gastrointest Endosc. 2009 Dec;70(6):1053-9. doi: 10.1016/j.gie.2009.07.020. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of sedation throughout the entire procedure | 3 months | No | |
Secondary | Duration of recovery after the endoscopic procedure | 3 months | No | |
Secondary | Rate of sedation-related complications during the procedure and the recovery phases | 3 months | No | |
Secondary | Rate of patients and physician satisfaction with sedation | 3 months | No |
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