Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery—A Multicenter, Randomized, Safety Assessor–Blinded Trial

Abstract

Complex 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.

Sugammadex: A Review of Neuromuscular Blockade Reversal

“…The trials included adults who were ASA physical status I-III [49,52,53] or I-IV [50,51] and undergoing surgery [50][51][52], laparoscopic surgery [49] or outpatient surgery [53] under general anaesthesia induced by propofol and maintained by propofol [49], sevoflurane [50,51] or inhalational agents [53], with opioids also permitted, or according to local practice [52]. Intravenous sugammadex 4 mg/kg was compared with neostigmine 50 or 70 lg/kg plus glycopyrrolate [50,51] or atropine [49], with placebo [52], or with spontaneous recovery [53].…”

“…The trials included adults who were ASA physical status I-III [49,52,53] or I-IV [50,51] and undergoing surgery [50][51][52], laparoscopic surgery [49] or outpatient surgery [53] under general anaesthesia induced by propofol and maintained by propofol [49], sevoflurane [50,51] or inhalational agents [53], with opioids also permitted, or according to local practice [52]. Intravenous sugammadex 4 mg/kg was compared with neostigmine 50 or 70 lg/kg plus glycopyrrolate [50,51] or atropine [49], with placebo [52], or with spontaneous recovery [53]. Patients receiving sugammadex underwent neuromuscular blockade with rocuronium [49,50,52,53] or vecuronium [51], patients receiving neostigmine underwent neuromuscular blockade with rocuronium [49,50] or vecuronium [51] and patients recovering spontaneously underwent neuromuscular blockade with rocuronium [52] or succinylcholine [53].…”

“…Intravenous sugammadex 4 mg/kg was compared with neostigmine 50 or 70 lg/kg plus glycopyrrolate [50,51] or atropine [49], with placebo [52], or with spontaneous recovery [53]. Patients receiving sugammadex underwent neuromuscular blockade with rocuronium [49,50,52,53] or vecuronium [51], patients receiving neostigmine underwent neuromuscular blockade with rocuronium [49,50] or vecuronium [51] and patients recovering spontaneously underwent neuromuscular blockade with rocuronium [52] or succinylcholine [53]. Reversal agents were administered at 1-2 PTCs, except in one trial in which neostigmine was administered at the reappearance of T 2 (i.e.…”

“…Randomized, safety assessor-blind, multicentre trials examined the efficacy of sugammadex administered at 1-2 PTCs for the reversal of deep neuromuscular blockade [49][50][51][52][53]. The trials included adults who were ASA physical status I-III [49,52,53] or I-IV [50,51] and undergoing surgery [50][51][52], laparoscopic surgery [49] or outpatient surgery [53] under general anaesthesia induced by propofol and maintained by propofol [49], sevoflurane [50,51] or inhalational agents [53], with opioids also permitted, or according to local practice [52].…”

Double blind Comparison of Rocuronium and Succinylcholine for endotracheal intubation in adult patients for elective surgeries

“…However, if an alternative agent is required, rocuronium 0.9 mg/kg can be used to create acceptable intubation conditions but should only be used as a second-line treatment because paralysis will be significantly prolonged. The introduction of sugammadex to facilitate reversal of rocuronium allows this problem to be overcome, but this drug is not currently widely available 12 .…”