drugset / Trial / NCT03809949
Opioid Free Versus Opioid Balanced Anesthesia
RandomizedParallel-groupTriple-blindTreatment
Summary
OPIOID FREE VERSUS OPIOID BALANCED ANAESTHESIA IN MIDDLE EAR SURGERY AIM OF THE WORK Primary aim: To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery Secondary aim: Monitoring analgesia, post-operative satisfaction and drowsiness.
Timeline
- Start
- 2019-01-16
- Primary completion
- 2019-05-21
- Completion
- 2019-05-22
Publications
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- Background Dhillon RS, East CA. Ear, nose, throat, and head and neck surgery: an illustrated colored text. 2nd ed. New York, Edinburgh: Churchill Livingstone;1999
- Background Deacock AR. Aspects of anaesthesia for middle ear surgery an blood loss during stapedectomy. Proc R Soc Med. 1971 Dec;64(12):1226-8. doi: 10.1177/003591577106401226. No abstract available.
- Background Miller RD. Miller's anesthesia, 6th ed. Vol 2. New York: Elsevier/Churchill Livingstone; 2005.
- Background Morgan EG, Mikhail MS, Murray MJ. Clinical anesthesiology. 4th ed. New York: Lange Medical Books/McGraw-Hill; 2006.
- Background Bailey CR. Management of outpatient ear, nose and throat surgery. Curr Opin Anaesthesiol. 2001 Dec;14(6):617-21. doi: 10.1097/00001503-200112000-00003.
- Background Honkavaara P, Saarnivaara L, Klemola UM. Prevention of nausea and vomiting with transdermal hyoscine in adults after middle ear surgery during general anaesthesia. Br J Anaesth. 1994 Dec;73(6):763-6. doi: 10.1093/bja/73.6.763.
- Background Fujii Y, Toyooka H, Tanaka H. Prophylactic antiemetic therapy with a combination of granisetron and dexamethasone in patients undergoing middle ear surgery. Br J Anaesth. 1998 Nov;81(5):754-6. doi: 10.1093/bja/81.5.754.
- Background Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children. Eur J Anaesthesiol. 1999 May;16(5):304-7. doi: 10.1046/j.1365-2346.1999.00483.x.
- Background Gombar S, Kaur J, Kumar Gombar K, Dass A, Singh A. Superior anti-emetic efficacy of granisetron-dexamethasone combination in children undergoing middle ear surgery. Acta Anaesthesiol Scand. 2007 May;51(5):621-4. doi: 10.1111/j.1399-6576.2007.01296.x.
- Background Bovill JG, Sebel PS, Stanley TH. Opioid analgesics in anesthesia: with special reference to their use in cardiovascular anesthesia. Anesthesiology. 1984 Dec;61(6):731-55.
- Background Long DR, Lihn AL, Friedrich S, Scheffenbichler FT, Safavi KC, Burns SM, Schneider JC, Grabitz SD, Houle TT, Eikermann M. Association between intraoperative opioid administration and 30-day readmission: a pre-specified analysis of registry data from a healthcare network in New England. Br J Anaesth. 2018 May;120(5):1090-1102. doi: 10.1016/j.bja.2017.12.044. Epub 2018 Mar 9.
- Background Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. 2005 Jun 15;62(12):1247-60; quiz 1261-2. doi: 10.1093/ajhp/62.12.1247.
- Background Macario A, Weinger M, Truong P, Lee M. Which clinical anesthesia outcomes are both common and important to avoid? The perspective of a panel of expert anesthesiologists. Anesth Analg. 1999 May;88(5):1085-91. doi: 10.1097/00000539-199905000-00023.
- Background Smith I, Terhoeve PA, Hennart D, Feiss P, Harmer M, Pourriat JL, Johnson IA. A multicentre comparison of the costs of anaesthesia with sevoflurane or propofol. Br J Anaesth. 1999 Oct;83(4):564-70. doi: 10.1093/bja/83.4.564.
- Background Smith I, Thwaites AJ. Target-controlled propofol vs. sevoflurane: a double-blind, randomised comparison in day-case anaesthesia. Anaesthesia. 1999 Aug;54(8):745-52. doi: 10.1046/j.1365-2044.1999.00953.x.
- Background Fleischmann E, Akca O, Wallner T, Arkilic CF, Kurz A, Hickle RS, Zimpfer M, Sessler DI. Onset time, recovery duration, and drug cost with four different methods of inducing general anesthesia. Anesth Analg. 1999 Apr;88(4):930-5. doi: 10.1097/00000539-199904000-00046.
- Background Fredman B, Nathanson MH, Smith I, Wang J, Klein K, White PF. Sevoflurane for outpatient anesthesia: a comparison with propofol. Anesth Analg. 1995 Oct;81(4):823-8. doi: 10.1097/00000539-199510000-00028.
- Background Shakir AAK, Ramachandra V, Hasan MA. Day surgery postoperative nausea and vomiting at home related to preoperative fentanyl. J One-day Surg 1997;6:10-1.
- Background Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Background Vandermeulen EP. Controlling the stress response. In: White PF (ed). Textbook of Intravenous Anesthesia. Baltimore: Williams & Wilkins; 1997. p. 565-79.
- Background Borgeat A, Wilder-Smith OH, Saiah M, Rifat K. Subhypnotic doses of propofol possess direct antiemetic properties. Anesth Analg. 1992 Apr;74(4):539-41. doi: 10.1213/00000539-199204000-00013.
- Background Gan TJ, Glass PSA. Balanced anesthesia. In: White PF (ed). Textbook of Intravenous Anesthesia. Baltimore: Williams & Wilkins; 1997. p. 347-74.
- Background Smith I. Inhalational anesthetic agents. In: Hemmings HC, Hopkins PM (eds). Foundations of Anesthesia. 2nd ed. London: Elsevier; 2005. p. 311-21.
- Background Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
- Background Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
- Background Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009.
- Background Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 1 mg/kg | Intravenous |