Remifentanil vs. propofol controlled infusion for sedation of patients undergoing gastrointestinal endoscopic procedures: A clinical randomized controlled clinical trial
Background: Target controlled infusion (TCI) for the administration of anesthesia may provide a safe alternative for managing the discomfort of patients undergoing gastrointestinal endoscopic procedures. However, the most appropriate drug available for TCI is yet to be established. The objective of this trial was to compare remifentanil vs. propofol in TCI for sedating patients during GI endoscopy.
Materials and methods: Sixty-nine patients requiring GI endoscopies were randomly distributed to receive remifentanil (n = 30) or propofol (n = 39) TCI at the effect site (e). The primary outcome was patient's satisfaction. Secondary outcomes included the gastroenterologist satisfaction, comparison of the percentage of adverse events between the two groups (occurrence of arrhythmias, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting and absence of amnesia), and the level of awareness. Retrospective registration number is NCT01746641 at Clinicaltrias.gov
Results: The mean (range) of patient satisfaction with remifentanil vs propofol was 1 (1-2) and 2 (11), respectively (Chi2, p < 0.001). Pain during the procedure was found to differ between remifentanil and propofol (mean 2 vs. 1, Chi2, p = 0.042), nausea or vomiting (4 vs. 0, Chi2, p = 0.01), and absence of amnesia (29 vs. 10, Chi2, p < 0.001), respectively. No statistically significant differences were found between the two groups.
Conclusion: Propofol in TCI seems to be an adequate agent for sedation of patients undergoing GI endoscopic procedures, with less adverse effects and higher patient satisfaction. Most likely, the combination of these two drugs may be synergistic and further reduce any adverse effects.
2. Schraag S, Flaschar J, Georgieff M. Target controlled infusion (TCI) - status and clinical perspectives. Anasthesiol Intensivmed Notfallmed Schmerzther. 2000;35:12-20.
3. Schraag S, Kreuer S, Bruhn J, Frenkel C, Albrecht S. Target-controlled infusion (TCI) - a concept with a future? State-of-the-art, treatment recommendations and a look into the future. Anaesthesist. 2008;57:223-30.
4. Masui K, Upton RN, Doufas AG, Coetzee JF, Kazama T, Mortier EP, et al. The performance of compartmental and physiologically based recirculatory pharmacokinetic models for propofol: a comparison using bolus, continuous, and target-controlled infusion data. Anesth Analg. 2010;111:368-79.
5. Coetzee JF, Glen JB, Wium CA, Boshoff L. Pharmacokinetic model selection for target controlled infusions of propofol. Assessment of three parameter sets. Anesthesiology. 1995;82:1328-45.
6. Struys MM, De Smet T, Depoorter B, Versichelen LF, Mortier EP, Dumortier FJ, et al. Comparison of plasma compartment versus two methods for effect compartment - controlled target-controlled infusion for propofol. Anesthesiology.2000;92:399-406.
7. Coppens M, Van Limmen JG, Schnider T, Wyler B, Bonte S, Dewaele F, et al. Study of the time course of the clinical effect of propofol compared with the time course of the predicted effect-site concentration: performance of three pharmacokinetic-dynamic models. Br J Anaesth. 2010;104:452-8.
8. Shibutani K, Inchiosa MA, Sawada K, Bairamian M. Accuracy of pharmacokinetic models for predicting plasma fentanyl concentrations in lean and obese surgical patients: derivation of dosing weight ("pharmacokinetic mass"). Anesthesiology. 2004;101:603-13.
9. De Castro V, Godet G, Mencia G, Raux M, Coriat P. Target-controlled infusion for remifentanil in vascular patients improves hemodynamics and decreases remifentanil requirement. Anesth Analg. 2003;96: 33-8.
10. Absalom AR, Mani V, De Smet T, Struys MM. Pharmacokinetic models for propofol - defining and illuminating the devil in the detail. Br J Anaesth. 2009;103:26-37.
11. Green SM, Krauss B. Procedural sedation terminology: moving beyond "conscious sedation". Ann EmergMed. 2002;39:433-5.
12. Mazanikov M, Udd M, Kylänpää L, Mustonen H, Lindström O, Halttunen J, et al. Patient-controlled sedation for ERCP: a randomized double-blind comparison of alfentanil and remifentanil. Endoscopy. 2012;44:487-92.
13. Mandel JE, Tanner JW, Lichtenstein GR, Metz DC, Katzka DA, Ginsberg GG, et al. A randomized, controlled, double-blind trial of patient-controlled sedation with propofol/remifentanil versus midazolam/fentanyl for colonoscopy. Anesth Analg. 2008;106:434-9.
14. Leslie K, Clavisi O, Hargrove J. Target-controlled infusion versus manually-controlled infusion of propofol for general anaesthesia or sedation in adults. Cochrane Database Syst Rev. 2008:CD006059.
15. Triem JG, Röhm KD, Boldt J, Piper SN. Comparison of a propofol-based anesthesia regimen using optimated-target-controlled-infusion (OTCI) and manually-controlled infusion (MCI) technique. Anasthesiol Intensivmed Notfallmed Schmerzther. 2006;41:150-5.
16. Liu SH, Wei W, Ding GN, Ke JD, Hong FX, Tian M. Relationship between depth of anesthesia and effect-site concentration of propofol during induction with the target-controlled infusion technique in elderly patients. Chin Med J (Engl). 2009;122:935-40.
17. Coskun D, Celebi H, Karaca G, Karabiyik L. Remifentanil versus fentanyl compared in a target-controlled infusion of propofol anesthesia: quality of anesthesia and recovery profile. J Anesth. 2010;24:373-9.
18. van den Nieuwenhuyzen MC, Engbers FH, Vuyk J, Burm AG. Target-controlled infusion systems: role in anaesthesia and analgesia. Clin Pharmacokinet. 2000;38:181-90.
19. Barakat AR, Sutcliffe N, Schwab M. Effect site concentration during propofol TCI sedation: a comparison of sedation score with two pharmacokinetic models. Anaesthesia. 2007;62:661-6. PubMed PMID: 17567340.
20. Guarracino F, Lapolla F, Cariello C, Danella A, Doroni L, Baldassarri R, et al. Target controlled infusion: TCI. MinervaAnestesiol. 2005;71:335-7.
21. Ihmsen H, Schraag S, Kreuer S, Bruhn J, Albrecht S. Target-controlled infusion. Clinical relevance and special features when using pharmacokinetic models. Anaesthesist. 2009;58:708-15.
22. Zhang X, He W, Wu X, Zhou X, Huang W, Feng X. TCI remifentanil vs. TCI propofol for awake fiber-optic intubation with limited topical anesthesia. Int J Clin Pharmacol Ther. 2012;50:10-6.
23. Chalumeau-Lemoine L, Stoclin A, Billard V, Laplanche A, Raynard B, Blot F. Flexible fiberoptic bronchoscopy and remifentanil target-controlled infusion in ICU: a preliminary study. Intensive Care Med. 2012, http://dx.doi.org/10.1007/s00134-012-2697-7O.
24. Sakaguchi M, Higuchi H, Maeda S, Miyawaki T. Dental sedation for patients with intellectual disability: a prospective study of manual control versus Bispectral Index-guided target-controlled infusion of propofol. J Clin Anesth. 2011;23:636-42.
25. Rai MR, Parry TM, Dombrovskis A, Warner OJ. Remifentanil target-controlled infusion vs propofol target-controlled infusion for conscious sedation for awake fibreoptic intubation: a double-blinded randomized controlled trial. Br J Anaesth. 2008;100:125-30.
26. Clouzeau B, Bui HN, Guilhon E, Grenouillet-Delacre M, Leger MS, Saghi T, et al. Fiberoptic bronchoscopy under noninvasive ventilation and propofol target-controlled infusion in hypoxemic patients. Intensive Care Med. 2011;37: 1969-75.
27. Motamed C, Salazar G. Awake fiberoptic intubation with target-controlled infusion of remifentanil in emergency surgery. J Opioid Manage. 2010;6:11.
28. Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974;22:656-9.
29. Neumar RW, Otto CW, Link MS, Kronick SL, Shuster M, Callaway CW, et al. Part 8: adult advanced cardiovascular life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010;122 Suppl. 3:S729-67.
30. Cohen J, Royston D. Remifentanil. Curr Opin Crit Care. 2001;7:227-31.
31. Battershill AJ, Keating GM. Remifentanil: a review of its analgesic and sedative use in the intensive care unit. Drugs. 2006;66:365-85.
32. Ellett ML. A literature review of the safety and efficacy of using propofol for sedation in endoscopy. Gastroenterol Nurs. 2010;33:111-7.
33. Servin FS, Billard V. Remifentanil and other opioids. Handb Exp Pharmacol. 2008;182:283-311.
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