NCT06962007 Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal
| NCT ID | NCT06962007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wonkwang University Hospital |
| Condition | Neuromuscular Blockade Reversal Agent |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-07-01 with a primary completion date of 2026-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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: * 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.
Contact & Investigator
Cheolhyeong Lee, MD
PRINCIPAL INVESTIGATOR
Wonkwang University Hospital
Frequently Asked Questions
Who can join the NCT06962007 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 70 Years, studying Neuromuscular Blockade Reversal Agent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06962007 currently recruiting?
Yes, NCT06962007 is actively recruiting participants. Contact the research team at ironyii70@gmail.com for enrollment information.
Where is the NCT06962007 trial being conducted?
This trial is being conducted at Iksan, South Korea.
Who is sponsoring the NCT06962007 clinical trial?
NCT06962007 is sponsored by Wonkwang University Hospital. The principal investigator is Cheolhyeong Lee, MD at Wonkwang University Hospital. The trial plans to enroll 240 participants.