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Study identifier: NCT06962007 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

Condition: Neuromuscular Blockade Reversal Agent · Perioperative Complications · Anesthesia, General  ·  Sponsor: Wonkwang University Hospital

PhaseNA
Planned participants240
Who can joinAll sexes, 19 Years to 70 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Cheol Lee, MD, PhD  ·  82-10-6613-1252  ·  ironyii70@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Wonkwang University hospitalIksan, Jeonbuk-do, South KoreaRecruiting

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Source record: clinicaltrials.gov/study/NCT06962007