Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

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.

NCT Number	NCT06962007
Lead Sponsor	Wonkwang University Hospital
Conditions	Neuromuscular Blockade Reversal Agent, Perioperative Complications, Anesthesia, General, Sugammadex, Monitoring, Intraoperative, Masseter Muscle Spasm
Enrollment	240 participants
Start Date	2025-07-01
Primary Completion	2026-09-20 (estimated)
Study Completion	2026-10-14 (estimated)
Updated on ClinicalTrials.gov	2026-07-07