A Randomized Clinical Study to Compare Low Dose of Sugammadex to Standard Dose of Neostigmine and Glycopyrrolate for the Reversal of Rocuronium Induced Moderate Neuromuscular Block

2023-3091

The aim of this study is to compare the use of a low dose sugammadex and neostigmine combined to glycopyrrolate to reverse a rocuronium induced moderate neuromuscular blockade.

2022-11-08

2023-12-19

2023-12-19

Completed

Early phase I

144

Inclusion Criteria: * ASA 1-3 patients, * Undergoing general anesthesia with rocuronium induced NMB, * TOF 1-3 at the end of surgery, * BMI \< 36 kg.m-2, * Age \> 18 years old Exclusion Criteria: * History of coronary artery disease and unstable before surgery * History of serious cardiac arrhythmia (including atrial fibrillation) * Renal or hepatic dysfunction * Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine * Neuromuscular disease * Allergy to any drug used in the study protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of patients randomized into Group "N" for neostigmine and group "S" for sugammadex for a total of 144 participants.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Two groups of patients randomized into Group "N" for neostigmine and group "S" for sugammadex. Group N will receive the standard reversal (neostigmine 50 µg.kg-1 and glycopyrrolate 7 µg.kg-1) and group S will receive sugammadex 0.5 mg.kg-1. Randomization will be done prior to the entrance in the OR, the day of the surgery.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 144, 'type': 'ACTUAL'}}

2024-02-20