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dc.contributor.authorLeslie, Ken_US
dc.contributor.authorChan, MTVen_US
dc.contributor.authorDarvall, JNen_US
dc.contributor.authorDe Silva, APen_US
dc.contributor.authorBraat, Sen_US
dc.contributor.authorDevlin, NJen_US
dc.contributor.authorPeyton, PJen_US
dc.contributor.authorRadnor, Jen_US
dc.contributor.authorLam, CKMen_US
dc.contributor.authorStory, DAen_US
dc.identifier.citation2021 Nov 9;7(1):200en_US
dc.description.abstractBackground: Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications. Methods: Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital). Results: Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5-4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67). Conclusions: A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible. Trial registration: Prospectively registered at the Australian and New Zealand Clinical Trials Registry ( ACTRN12620001313921 ) on December 7, 2020. .en_US
dc.subjectNeuromuscular blockadeen_US
dc.titleSugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trialen_US
dc.typeJournal Articleen_US
dc.identifier.journaltitlePilot and feasibility studiesen_US
dc.description.affiliatesUniversity of Melbourneen_US
dc.type.studyortrialPilot/Feasibility Studyen_US
dc.identifier.studynameThe SNAPP Pilot Study: Suggamedex, Neostigimine and Postoperative Pulmonary Complicationsen_US
item.openairetypeJournal Article-
item.fulltextNo Fulltext-
Appears in Collections:Scholarly and Clinical
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