Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

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.

Conditions

• Neuromuscular Blockade Reversal Agent
• Perioperative Complications
• Anesthesia, General
• Sugammadex
• Monitoring, Intraoperative
• Masseter Muscle Spasm

Interventions

DRUG

Sugammadex 1 mg/kg Group

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

DRUG

Sugammadex 2 mg/kg Group

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

DRUG

Sugammadex 4 mg/kg Group

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

DRUG

Pyridostigmine/Glycopyrrolate Group

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

Sponsors & Collaborators

• Wonkwang University Hospital

  lead OTHER

Principal Investigators

• Cheolhyeong Lee, MD · Wonkwang University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2025-05-20

Completion

2025-07-14

Countries

• South Korea

Study Locations