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Randomized Controlled Trial Multicenter Study Comparative Study
Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial.
- Roy Soto, Jonathan S Jahr, Janet Pavlin, Daniel Sabo, Beverly K Philip, Talmage D Egan, Everton Rowe, Joris de Bie, and Tiffany Woo.
- 1Department of Anesthesiology, Beaumont Health System, Royal Oak, MI; 2Department of Anesthesiology, David Geffen School of Medicine at UCLA, Los Angeles, CA; 3Department of Anesthesiology and Pain Medicine, University of Washington Medical Center, Seattle, WA; 4Department of Anesthesiology, UPMC Shadyside Hospital, Pittsburgh, PA; 5Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; 6Department of Anesthesiology, University of Utah Health Sciences Center, Salt Lake City, UT; and 7Merck Sharp & Dohme Corp, Whitehouse Station, NJ.
- Am J Ther. 2016 Nov 1; 23 (6): e1654-e1662.
AbstractComplex surgical procedures are increasingly performed in an outpatient setting, with emphasis on rapid recovery and case turnover. In this study, the combination of rocuronium for neuromuscular blockade (NMB) reversed by single-dose sugammadex was compared with succinylcholine followed by spontaneous recovery in outpatient surgery. This multicenter, randomized, safety assessor-blinded study enrolled adults undergoing a short elective outpatient surgical procedure requiring NMB and tracheal intubation. Patients were randomized to NMB with either rocuronium 0.6 mg/kg for tracheal intubation with incremental doses of rocuronium 0.15 mg/kg and subsequent reversal with sugammadex 4.0 mg/kg at 1-2 posttetanic counts or succinylcholine 1.0 mg/kg for intubation with spontaneous recovery. The primary efficacy end point was the time from sugammadex administration to recovery of the train-of-four ratio to 0.9; for succinylcholine, time from administration to recovery of the first twitch (T1) to 90% was assessed. From 167 patients enrolled, 150 received treatment. The all-subjects-treated population comprised 70 patients in the rocuronium-sugammadex group and 80 in the succinylcholine group. Geometric mean (95% confidence interval) time from the start of sugammadex administration to recovery of the train-of-four ratio to 0.9 was 1.8 (1.6-2.0) minutes. Geometric mean (95% confidence interval) time from succinylcholine administration to recovery of T1 to 90% was 10.8 (10.1-11.5) minutes. Health outcome variables were similar between the groups. Adverse events were reported in 87.1% and 93.8% of patients for rocuronium-sugammadex and succinylcholine, respectively. In conclusion, rocuronium for intubation followed by sugammadex for reversal of NMB offers a viable treatment option in outpatient surgery without prolonging recovery duration or jeopardizing safety.
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