Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

NCT06962007 NA COMPLETED

Study Objective: This study aims to evaluate the incidence, severity, and risk factors of sugammadex-induced mouth clenching during neuromuscular blockade (NMB) reversal in adult surgical patients. Study Design: This prospective, randomized, double-blind, controlled clinical trial enrolls adult patients (ASA physical status I-II, aged 19-70 years) undergoing elective surgery under general anesthesia with rocuronium. Patients will be randomized into four groups to receive either sugammadex at doses of 1 mg/kg, 2 mg/kg, or 4 mg/kg, or a combination of pyridostigmine and glycopyrrolate. Primary Outcome: The primary outcome is the incidence of clenching within 10 minutes after NMB reversal, assessed by clinical observation, masseter EMG, and airway pressure changes, using a novel five-grade severity scale. Secondary Outcomes: Secondary outcomes include the severity of clenching, time to TOF ratio ≥0.9, BIS values at clenching onset, complications, and identification of risk factors such as dose, sex, BIS, age, BMI, and rocuronium dose. Significance: This study seeks to improve perioperative safety by identifying modifiable risk factors and informing dose adjustments or alternative reversal strategies to prevent sugammadex-induced clenching, particularly in high-risk populations.

Details

Lead sponsor	Wonkwang University Hospital
Phase	NA
Status	COMPLETED
Enrolment	240
Start date	Thu May 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Neuromuscular Blockade Reversal Agent
• Perioperative Complications
• Anesthesia, General
• Sugammadex
• Monitoring, Intraoperative
• Masseter Muscle Spasm

Interventions

• Sugammadex 1 mg/kg Group
• Sugammadex 2 mg/kg Group
• Sugammadex 4 mg/kg Group
• Pyridostigmine/Glycopyrrolate Group

Countries

South Korea