Sugammadex-Induced Mouth Clenching After Reversing Neuromuscular Blockade

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, double-blind study enrolling adults 19 to 70 years old with ASA I-II status undergoing elective surgery with rocuronium-induced neuromuscular blockade. Participants are assigned to receive sugammadex at 1, 2, or 4 mg/kg, or a pyridostigmine/glycopyrrolate combination, to see how often and how severely jaw clenching occurs within 10 minutes of reversal. Clenching is measured by clinical observation, masseter EMG, and airway pressure changes, using a five-level severity scale. Secondary outcomes include timing to TOF ratio recovery, BIS values at clenching onset, airway complications, and identification of risk factors. The study aims to clarify safety signals related to airway management and patient comfort during emergence from anesthesia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Wonkwang University hospital
  Iksan, Jeonbuk-do, South Korea Recruiting

Study contacts

• Principal investigator: Cheolhyeong Lee, MD — Wonkwang University Hospital
• Study coordinator: Cheol Lee, MD, PhD
• Email: ironyii70@gmail.com
• Phone: 82-10-6613-1252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.