RecruitingNot ApplicableNCT06962007

Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

A Prospective, Randomized, Double-Blind Study of the Incidence, Severity, and Risk Factors of Clenching Induced by Sugammadex During Neuromuscular Blockade Reversal


Sponsor

Wonkwang University Hospital

Enrollment

240 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 19 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pyridostigmine/Glycopyrrolate Group, a drug called Sugammadex 1 mg/kg Group, and others for people with anesthesia general, masseter muscle spasm, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSugammadex 1 mg/kg Group

Participants receive 1 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.

DRUGSugammadex 2 mg/kg Group

Participants receive 2 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.

DRUGSugammadex 4 mg/kg Group

Participants receive 4 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.

DRUGPyridostigmine/Glycopyrrolate Group

Participants receive pyridostigmine 0.2 mg/kg and glycopyrrolate 0.01 mg/kg intravenously for reversal of rocuronium-induced neuromuscular blockade.


Locations(1)

Wonkwang University hospital

Iksan, Jeonbuk-do, South Korea

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NCT06962007


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