A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants
10.3760/cma.j.cn131073.20220107.00104
- VernacularTitle:舒更葡糖钠用于ASA分级Ⅲ或Ⅳ级高风险手术患者安全性的评价：随机双盲临床研究
- Author:
W. Herring JOSEPH
1
;
Yuki MUKAI
;
Aobo WANG
;
Jeannine LUTKIEWICZ
;
F. John LOMBARD
;
Li LIN
;
Molly WATKINS
;
M. David BROUSSARD
;
Manfred BLOBNER
Author Information
1. 美国默克集团临床研究部，肯纳尔沃斯堡，新泽西州 07033，美国
- Keywords:
Sugammadex;
Safety;
ASA physical class 3 or 4
- From:
Chinese Journal of Anesthesiology
2022;42(1):16-23
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The aim of this randomized, double-blind trial was to evaluate the safety and tolerability profile, including cardiac safety, of sugammadex-mediated recovery from neuromuscular block in participants undergoing surgery who met the American Society of Anesthesiologists (ASA) Physical Class 3 or 4 criteria.Specifically, this study assessed the impact of sugammadex on cardiac adverse events (AEs) and other prespecified AEs of clinical interest.Methods:Participants meeting ASA Class 3 and 4 criteria were stratified by ASA Class and NMBA (rocuronium or vecuronium) then randomized to one of the following: 1) Moderate neuromuscular block, sugammadex 2 mg/kg; 2) Moderate neuromuscular block, neostigmine and glycopyrrolate (neostigmine/glycopyrrolate); 3) Deep neuromuscular block, sugammadex 4 mg/kg; 4) Deep neuromuscular block, sugammadex 16 mg/kg (rocuronium only). Primary endpoints included incidences of treatment-emergent (TE) sinus bradycardia, TE sinus tachycardia and other TE cardiac arrhythmias.Results:Of 344 participants randomized, 331 received treatment (61% male, BMI 28.5 ± 5.3 kg/m 2, age 69 ± 11 years). 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 3 or 4 participants.
