drugset / Trial / NCT02039453
Safety and Efficacy of Fentanyl Versus Pethidine During Propofol-based Sedated Colonoscopy: Prospective Randomized Study
RandomizedParallel-groupSingle-blindHealth-services research
Summary
During sedative colonoscopy, use of propofol have been increased world wide. The onset time of propofol is shorter than midazolam. However the most popular additive pain killer, pethidine show different pharmacodynamic feature. The pethidine has longer onset time than propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of fentanyl has been increased world widely. However, exact comparison of pethidine and fentanyl was not studied. Therefore, we designed this study to compare both drug to check satisfaction of this drug.
Timeline
- Start
- 2013-09
- Primary completion
- 2015-08
- Completion
- 2015-08
Publications
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- Background Mandel JE, Lichtenstein GR, Metz DC, Ginsberg GG, Kochman ML. A prospective, randomized, comparative trial evaluating respiratory depression during patient-controlled versus anesthesiologist-administered propofol-remifentanil sedation for elective colonoscopy. Gastrointest Endosc. 2010 Jul;72(1):112-7. doi: 10.1016/j.gie.2010.01.031. Epub 2010 May 20.
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- Background Molina-Infante J, Duenas-Sadornil C, Mateos-Rodriguez JM, Perez-Gallardo B, Vinagre-Rodriguez G, Hernandez-Alonso M, Fernandez-Bermejo M, Gonzalez-Huix F. Nonanesthesiologist-administered propofol versus midazolam and propofol, titrated to moderate sedation, for colonoscopy: a randomized controlled trial. Dig Dis Sci. 2012 Sep;57(9):2385-93. doi: 10.1007/s10620-012-2222-4. Epub 2012 May 22.
- Background Mui LM, Teoh AY, Ng EK, Lee YT, Au Yeung AC, Chan YL, Lau JY, Chung SC. Premedication with orally administered midazolam in adults undergoing diagnostic upper endoscopy: a double-blind placebo-controlled randomized trial. Gastrointest Endosc. 2005 Feb;61(2):195-200. doi: 10.1016/s0016-5107(04)02590-8.
- Background Ozel AM, Oncu K, Yazgan Y, Gurbuz AK, Demirturk L. Comparison of the effects of intravenous midazolam alone and in combination with meperidine on hemodynamic and respiratory responses and on patient compliance during upper gastrointestinal endoscopy: a randomized, double-blind trial. Turk J Gastroenterol. 2008 Mar;19(1):8-13.
- Background 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.
- Background 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. doi: 10.1111/j.1572-0241.2002.05908.x.
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- Background Riphaus A, Rabofski M, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: results from the first nationwide survey. Z Gastroenterol. 2010 Mar;48(3):392-7. doi: 10.1055/s-0028-1109765. Epub 2010 Feb 5.
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- Background Tox U, Schumacher B, Toermer T, Terheggen G, Mertens J, Holzapfel B, Lehmacher W, Goeser T, Neuhaus H. Propofol sedation for colonoscopy with a new ultrathin or a standard endoscope: a prospective randomized controlled study. Endoscopy. 2013 Jun;45(6):439-44. doi: 10.1055/s-0032-1326270. Epub 2013 Mar 6.
- Background Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463.
- Background Ulmer BJ, Hansen JJ, Overley CA, Symms MR, Chadalawada V, Liangpunsakul S, Strahl E, Mendel AM, Rex DK. Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists. Clin Gastroenterol Hepatol. 2003 Nov;1(6):425-32. doi: 10.1016/s1542-3565(03)00226-x.
- Background Usta B, Turkay C, Muslu B, Gozdemir M, Kasapoglu B, Sert H, Demircioglu RI, Karabayirli S. Patient-controlled analgesia and sedation with alfentanyl versus fentanyl for colonoscopy: a randomized double blind study. J Clin Gastroenterol. 2011 Aug;45(7):e72-5. doi: 10.1097/MCG.0b013e318201fbce.
- Background 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. doi: 10.1111/j.1572-0241.2006.00760.x.
- Background Wang D, Wang S, Chen J, Xu Y, Chen C, Long A, Zhu Z, Liu J, Deng D, Chen J, Tang D, Wang L. Propofol combined with traditional sedative agents versus propofol- alone sedation for gastrointestinal endoscopy: a meta-analysis. Scand J Gastroenterol. 2013 Jan;48(1):101-10. doi: 10.3109/00365521.2012.737360. Epub 2012 Oct 31.
- Background Wang F, Shen SR, Xiao DH, Xu CX, Tang WL. Sedation, analgesia, and cardiorespiratory function in colonoscopy using midazolam combined with fentanyl or propofol. Int J Colorectal Dis. 2011 Jun;26(6):703-8. doi: 10.1007/s00384-011-1162-3. Epub 2011 Mar 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | 50 ug | — |
| Subject | Fentanyl | Other / unclassified | 75 ug | — |
| Subject | Fentanyl | Other / unclassified | 100 ug | — |
| Comparator | Meperidine | Unknown | 25 mg | Intravenous |
| Comparator | Meperidine | Unknown | 50 mg | Intravenous |
| Background | Propofol | Small molecule | 20 mg | Intravenous |
Indications
No indication recorded.