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.
Eligible participants are adults aged 19-70 years, American Society of Anesthesiologists (ASA) physical status I-II, undergoing elective surgery under general anesthesia with rocuronium.
Exclusion criteria include neuromuscular disorders, renal impairment (creatinine clearance < 30 mL/min), history of clenching or dental disease, allergy to study drugs, or emergency surgery.