Vecuronium bromide 10mg powder and solvent for solution for injection vials

BackgroundSugammadex and neostigmine are used to reverse aminosteroid neuromuscular-blocking drugs at the end of surgery. We aimed to determine whether reversal of neuromuscular blockade with sugammadex reduces the incidence of postoperative pulmonary complications or death compared with neostigmine.MethodsWe conducted a pragmatic, international, multicentre, randomised, controlled, phase 4 trial involving 44 hospitals in Australia, Aotearoa New Zealand, and Hong Kong. Eligible patients were adults (aged ≥40 years) who were having abdominal or thoracic surgery under general anaesthesia and lasting at least 2 h, with an expected postoperative hospital stay of 1 night or longer. Patients were randomly assigned (1:1) to sugammadex or neostigmine, administered intravenously in doses chosen by the attending anaesthesiologist, for reversal of rocuronium-induced or vecuronium-induced neuromuscular blockade at the end of surgery. Randomisation was done via a web-based service, in random permuted blocks of varying sizes of 2 and 4 and stratified by centre. Patients, research staff who were responsible for outcome assessments, and members of the endpoint adjudication committee were masked to group assignment. The primary outcome was postoperative pulmonary complications or death up to hospital discharge (or postoperative day 7 if still in hospital). The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000394640) and is closed to accrual.FindingsPatients were recruited between July 21, 2023, and July 3, 2025; 3498 patients were included in the intention-to-treat population (1745 [49·9%] in the sugammadex group and 1753 [50·1%] in the neostigmine group). Postoperative pulmonary complications or death occurred in 331 (19·0%) of 1743 patients in the sugammadex group and 377 (21·5%) of 1752 patients in the neostigmine group (risk ratio [RR] 0·88 [95% CI 0·77-1·00]; p=0·049). Death occurred in one (0·1%) and two (0·1%) patients (RR 0·50 [95% CI 0·05-5·53]; p >0·99), atelectasis in 320 (18·4%) of 1742 patients and 370 (21·1%) of 1750 patients (0·86 [0·76-0·99]; p=0·030), pneumonia in 37 (2·1%) of 1742 patients and 38 (2·2%) of 1750 patients (0·98 [0·62-1·53]; p=0·92), and pulmonary aspiration in four (0·2%) of 1742 and seven (0·4%) of 1750 patients (0·57 [0·17-1·96]; p=0·38) in the sugammadex and neostigmine groups, respectively. Acute respiratory distress syndrome was not reported. No adverse events were deemed to be treatment related.InterpretationSugammadex reduced the incidence of postoperative pulmonary complications or death compared with neostigmine. The risk reduction was small with atelectasis of uncertain clinical significance being the most common complication. Sugammadex can be considered as a first-line drug for reversal of aminosteroid-induced neuromuscular blockade at the end of surgery.FundingAustralian Medical Research Future Fund and the Hong Kong Health and Medical Research Fund.

Abstract licence: CC BY