A large Australian-led trial has found sugammadex cuts the risk of lung complications or death after major surgery compared with neostigmine.
Patients given sugammadex had a postoperative pulmonary complication or died in 19.0% of cases, against 21.5% for those given neostigmine (RR 0.88, 95% CI 0.77 to 1.00; p=0.049). The number needed to treat was 47.
Atelectasis drove most of that difference, occurring in 18.4% of the sugammadex group versus 21.1% of the neostigmine group (RR 0.86, 95% CI 0.76 to 0.99; p=0.030). The authors Professor Kate Leslie of the University of Melbourne and Royal Melbourne Hospital were careful not to oversell the finding. “The risk reduction was small with atelectasis of uncertain clinical significance being the most common complication,” they wrote.
Still, they argued the result mattered given how often these drugs are used. “This result remains clinically significant given the millions of patients receiving neuromuscular-blocking drugs to facilitate major abdominal and thoracic surgery every year,” they wrote.
They added: “Sugammadex can be considered as a first-line drug for reversal of aminosteroid-induced neuromuscular blockade at the end of surgery.”
The trial also found sugammadex produced more reliable reversal. A train-of-four ratio of 0.9 or higher at extubation, the threshold for adequate reversal, was reached in 87.4% of sugammadex patients compared with 64.3% of those given neostigmine. Rescue reversal was needed in just 3.6% of the sugammadex group, against 17.2% in the neostigmine group.
Despite earlier meta-analyses and updated guidelines suggesting sugammadex should reduce postoperative nausea and vomiting, the trial found no difference between the groups, a result the authors said “should resolve the controversy surrounding reversal of neuromuscular blockade and postoperative nausea and vomiting”.
Rates of pneumonia, aspiration pneumonitis and death were similar between the two groups, and no cases of acute respiratory distress syndrome were recorded. Death occurred in one patient given sugammadex and two given neostigmine, a difference the authors said was not statistically significant.
The phase 4 trial, published online in The Lancet Respiratory Medicine [link here] randomised 3498 patients aged 40 and over across 44 hospitals in Australia, New Zealand and Hong Kong. All were having abdominal or thoracic surgery lasting at least two hours, with reversal of rocuronium or vecuronium induced neuromuscular blockade.
The trial also exposed a familiar problem with monitoring. Quantitative neuromuscular monitoring was used in only 84% of patients overall, despite guidelines from the Australian and New Zealand College of Anaesthetists recommending its routine use. The authors noted that “numerous attempts to have complete and sustained compliance in clinical practice have largely failed and new strategies are required”.
The trial was funded by the Australian Medical Research Future Fund and the Hong Kong Health and Medical Research Fund, with the authors declaring no competing interests. Follow-up for the primary outcome was completed for 99.8% of patients.