Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine

MSD-IIS-54809

The purpose of this study is to determine if the use of sugammadex (compared with neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).

2018-12-03

2020-04-01

2021-01-01

Terminated

Early phase I

30

Inclusion Criteria: * age \>18 * patients presenting for non-cardiac surgery * planned operative time of over 1 hour * plan to be intubated and to receive muscle relaxants for their surgery * plan to stay at least one night in hospital Exclusion Criteria: * Previous recruitment to the trial * Hypersensitivity to any of the study drugs * Patient refusal * Cognitive Impairment, or language proficiency leading to inability to complete QoR-15 questionnaire * Body Mass Index (BMI) \>40 * Planned postoperative intubation and ventilation * Liver failure with Child-Pugh class B/C * Renal failure with either regular peritoneal or haemodialysis or serum creatinine \>140mcgmol/L * Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-03-29