drugset / Trial / NCT02860507
Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)
Timeline
- Start
- 2016-08
- Primary completion
- 2018-02
- Completion
- 2018-02
Publications
- Background Turner DA, Smith G. Evaluation of the combined effects of atropine and neostigmine on the lower oesophageal sphincter. Br J Anaesth. 1985 Oct;57(10):956-9. doi: 10.1093/bja/57.10.956.
- Background Proakis AG, Harris GB. Comparative penetration of glycopyrrolate and atropine across the blood--brain and placental barriers in anesthetized dogs. Anesthesiology. 1978 May;48(5):339-44. doi: 10.1097/00000542-197805000-00007. No abstract available.
- Background Chhibber AK, Lustik SJ, Thakur R, Francisco DR, Fickling KB. Effects of anticholinergics on postoperative vomiting, recovery, and hospital stay in children undergoing tonsillectomy with or without adenoidectomy. Anesthesiology. 1999 Mar;90(3):697-700. doi: 10.1097/00000542-199903000-00010.
- Background Tramer MR, Fuchs-Buder T. Omitting antagonism of neuromuscular block: effect on postoperative nausea and vomiting and risk of residual paralysis. A systematic review. Br J Anaesth. 1999 Mar;82(3):379-86. doi: 10.1093/bja/82.3.379.
- Background Cheng CR, Sessler DI, Apfel CC. Does neostigmine administration produce a clinically important increase in postoperative nausea and vomiting? Anesth Analg. 2005 Nov;101(5):1349-1355. doi: 10.1213/01.ANE.0000180992.76743.C9.
- Background Naguib M, Brull SJ. Update on neuromuscular pharmacology. Curr Opin Anaesthesiol. 2009 Aug;22(4):483-90. doi: 10.1097/ACO.0b013e32832b8cff.
- Background Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
- Background Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.
- Background Hemmerling TM, Zaouter C, Geldner G, Nauheimer D. Sugammadex--a short review and clinical recommendations for the cardiac anesthesiologist. Ann Card Anaesth. 2010 Sep-Dec;13(3):206-16. doi: 10.4103/0971-9784.69052.
- Background Abad-Gurumeta A, Ripolles-Melchor J, Casans-Frances R, Espinosa A, Martinez-Hurtado E, Fernandez-Perez C, Ramirez JM, Lopez-Timoneda F, Calvo-Vecino JM; Evidence Anaesthesia Review Group. A systematic review of sugammadex vs neostigmine for reversal of neuromuscular blockade. Anaesthesia. 2015 Dec;70(12):1441-52. doi: 10.1111/anae.13277.
- Background Koyuncu O, Turhanoglu S, Ozbakis Akkurt C, Karcioglu M, Ozkan M, Ozer C, Sessler DI, Turan A. Comparison of sugammadex and conventional reversal on postoperative nausea and vomiting: a randomized, blinded trial. J Clin Anesth. 2015 Feb;27(1):51-6. doi: 10.1016/j.jclinane.2014.08.010. Epub 2014 Dec 24.
- Background Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440.
- Background Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
- Background Herbstreit F, Peters J, Eikermann M. Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2009 Jun;110(6):1253-60. doi: 10.1097/ALN.0b013e31819faa71.
- Background Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Nisman M. Intraoperative acceleromyographic monitoring reduces the risk of residual neuromuscular blockade and adverse respiratory events in the postanesthesia care unit. Anesthesiology. 2008 Sep;109(3):389-98. doi: 10.1097/ALN.0b013e318182af3b.
- Background Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24.
- Background Della Rocca G, Pompei L, Pagan DE Paganis C, Tesoro S, Mendola C, Boninsegni P, Tempia A, Manstretta S, Zamidei L, Gratarola A, Murabito P, Fuggiano L, DI Marco P. Reversal of rocuronium induced neuromuscular block with sugammadex or neostigmine: a large observational study. Acta Anaesthesiol Scand. 2013 Oct;57(9):1138-45. doi: 10.1111/aas.12155. Epub 2013 Jul 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Neostigmine | Other / unclassified | 0.06 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 4 mg/kg | — |
| Comparator | Glycopyrrolate | Small molecule | 0.04 mg/kg | Intravenous |
Indications
No indication recorded.