Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

Recruiting now · Not applicable

Conditions studied: Neuromuscular Blockade Reversal Agent, Perioperative Complications, Anesthesia, General, Sugammadex, Monitoring, Intraoperative, Masseter Muscle Spasm

In brief

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.

Key facts

Study ID: NCT06962007
Run by: Wonkwang University Hospital
People needed: 240
Starts: 2025-07-01
Expected to finish: 2026-10-14
Last updated by the study team: 2026-07-07

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Wonkwang University hospital — Iksan, Jeonbuk-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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