Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

Wonkwang University Hospital

Status: Not yet enrolling

Conditions: Perioperative Complications; Sugammadex; Masseter Muscle Spasm; Monitoring, Intraoperative; Anesthesia, General; Neuromuscular Blockade Reversal Agent

Treatments: Drug: Sugammadex 4 mg/kg Group; Drug: Sugammadex 2 mg/kg Group; Drug: Pyridostigmine/Glycopyrrolate Group; Drug: Sugammadex 1 mg/kg Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06962007

Wonkwang UH17

Details and patient eligibility

About

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 18-70 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.

Full description

This prospective, randomized, double-blind clinical trial aims to investigate the incidence, risk factors, and clinical implications of sugammadex-induced clenching during neuromuscular blockade reversal under general anesthesia. Sugammadex, a selective relaxant binding agent, is widely used for the rapid reversal of rocuronium-induced neuromuscular blockade. However, reports of jaw clenching and masseter muscle contraction following sugammadex administration have raised safety concerns, particularly regarding airway management and patient discomfort during emergence from anesthesia.

A total of 240 adult patients (ASA physical status I-II, aged 18 to 70 years) scheduled for elective surgery under general anesthesia with rocuronium will be enrolled. Participants will be randomly assigned to one of four groups in a 1:1:1:1 ratio: sugammadex 1 mg/kg (S1), 2 mg/kg (S2), 4 mg/kg (S4), or pyridostigmine 0.2 mg/kg with glycopyrrolate 0.01 mg/kg (PG) as the control. Clenching events will be assessed within 10 minutes of drug administration using three criteria: visible jaw clenching, increased masseter electromyographic (EMG) activity (>50 μV for ≥2 seconds), and a rise in airway pressure (>5 cm H₂O). Severity will be graded using a novel five-level classification system.

Secondary outcomes include the severity and timing of clenching, time to train-of-four (TOF) ratio ≥0.9, bispectral index (BIS) value at the time of clenching onset, airway-related complications, and risk factor analysis based on dose, sex, BIS, age, BMI, and total rocuronium dose.

P"This study hypothesizes a dose-dependent increase in clenching with higher doses of sugammadex, potentially with a higher incidence in female patients and those with higher BIS values at reversal."

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups

Sugammadex 1 mg/kg Group (S1)

Experimental group

Description:

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

Treatment:

Drug: Sugammadex 1 mg/kg Group

Sugammadex 2 mg/kg Group (S2)

Experimental group

Description:

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

Treatment:

Drug: Sugammadex 2 mg/kg Group

Sugammadex 4 mg/kg Group (S4)

Experimental group

Description:

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

Treatment:

Drug: Sugammadex 4 mg/kg Group

Pyridostigmine/Glycopyrrolate Group (PG)

Active Comparator group

Description:

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

Treatment:

Drug: Pyridostigmine/Glycopyrrolate Group