Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

Not Applicable

Not yet recruiting

• Conditions: Neuromuscular Blockade Reversal Agent; Perioperative Complications; Anesthesia, General; Sugammadex; Monitoring, Intraoperative; Masseter Muscle Spasm
• Interventions: Drug: Pyridostigmine/Glycopyrrolate Group; Drug: Sugammadex 1 mg/kg Group; Drug: Sugammadex 2 mg/kg Group; Drug: Sugammadex 4 mg/kg Group

• Registration Number: NCT06962007
• Lead Sponsor: Wonkwang University Hospital

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 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.

Detailed 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."

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-27
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study Start: 2025-05-01
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pyridostigmine/Glycopyrrolate Group (PG)	Pyridostigmine/Glycopyrrolate Group	Participants receive pyridostigmine 0.2 mg/kg and glycopyrrolate 0.01 mg/kg intravenously for reversal of rocuronium-induced neuromuscular blockade.
Sugammadex 1 mg/kg Group (S1)	Sugammadex 1 mg/kg Group	Participants receive 1 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
Sugammadex 2 mg/kg Group (S2)	Sugammadex 2 mg/kg Group	Participants receive 2 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
Sugammadex 4 mg/kg Group (S4)	Sugammadex 4 mg/kg Group	Participants receive 4 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.

Primary Outcome Measures

Name	Time	Method
Incidence of Mouth Clenching After Neuromuscular Blockade Reversal	Within 10 minutes after administration of neuromuscular blockade reversal agent	Clenching is defined as any of the following occurring within 10 minutes after administration of neuromuscular blockade reversal agents: (1) visible jaw clenching observed by the anesthesiologist, (2) masseter muscle electromyography (EMG) activity greater than 50 μV sustained for ≥2 seconds, or (3) airway pressure increase \>5 cm H₂O.

Secondary Outcome Measures

Name	Time	Method
Severity of Mouth Clenching	Within 10 minutes after reversal agent administration	Graded using a novel five-grade severity scale based on degree of jaw closure, EMG intensity, airway pressure, and need for intervention.
Time to Recovery of Train-of-Four (TOF) Ratio ≥0.9	Up to 10 minutes after administration	Measured using peripheral nerve stimulator; defined as time from reversal agent injection to TOF ratio ≥0.9.
Peak Airway Pressure	Within 10 minutes post-reversal	Maximum airway pressure measured within 10 minutes after administration of reversal agent.
Bispectral Index (BIS) at Clenching Onset	At time of clenching event, within 10 minutes post-reversal	BIS value recorded at the time clenching is first detected.
Incidence of Clenching-Related Complications	Within 10 minutes post-reversal	Incidents such as bite injury, airway obstruction, or need for additional airway intervention during or after reversal.

Trial Locations

Locations (1)

Wonkwang University hospital; 🇰🇷 Iksan, Jeonbuk-do, Korea, Republic of