A Randomized Trial Evaluating the Safety Profile of Sugammadex in Major Surgeries Involving ASA Physical Class 1 or 2 Participants

BACKGROUND: Sugammadex, a modified cyclodextrin, reverses neuromuscular blockade from the neuromuscular blocking agents.(1) It encapsulates unbound rocuronium or vecuronium providing rapid and predictable reversal and avoiding anticholinesterase side effects and antimuscarinic drug use.(2) Studies confirm the safety and efficacy of sugammadex for reversal of moderate or deep, rocuronium- or vecuronium-induced neuromuscular block.(3,4) However, randomized clinical trial data are limited in assessing treatment emergent cardiac adverse events. AIM/OBJECTIVE: The aim of this randomized, double-blind trial was to evaluate the safety and tolerability profile, cardiac adverse events (AEs) and other prespecified AEs of clinical interest of sugammadex-mediated recovery from neuromuscular block in participants undergoing surgery who met the American Society of Anesthesiologists (ASA) Physical Class 1 or 2 criteria. METHODS: Participants meeting ASA Class 1 and 2 criteria undergoing GA and using rocuronium as NMBA were randomized to one of the following: sugammadex 2 mg/kg; sugammadex 4 mg/kg; and neostigmine 0.05 mg/kg and glycopyrrolate. Primary endpoints included incidences of treatment-emergent (TE) sinus bradycardia, TE sinus tachycardia and other TE cardiac arrhythmias. RESULTS: Of 63 participants randomized, 21 received sugammadex 2 mg/kg, 21 received sugammadex 4 mg/kg, 21 received neostigmine 0.05mg/kg and glycopyrrolate for reversal. Incidence of TE sinus bradycardia was significantly lower in the sugammadex 2 mg/kg group vs neostigmine+glycopyrrolate. The incidence of TE sinus tachycardia was significantly lower in the sugammadex 2 and 4 mg/kg groups vs neostigmine/glycopyrrolate. No significant differences in other TE cardiac arrythmias were seen between sugammadex groups and neostigmine/glycopyrrolate. There were no cases of adjudicated anaphylaxis or hypersensitivity reactions in this study. CONCLUSIONS: Compared with neostigmine/glycopyrrolate, incidence of TE sinus bradycardia was significantly lower with sugammadex 2 mg/kg and incidence of TE sinus tachycardia was significantly lower with sugammadex 2 mg/kg and 4 mg/kg. These results support the safety of sugammadex for reversing rocuronium- or vecuronium-induced moderate and deep neuromuscular block in ASA Class 1 or 2 participants.