Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-07-14

Brief Summary

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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.

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Detailed Description

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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 19 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.

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."

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is not a safety/efficacy verification aimed at drug approval, but a mechanism/dose-related study to evaluate the dose-response and adverse event rate of already approved drugs.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sugammadex 1 mg/kg Group (S1)

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

Group Type EXPERIMENTAL

Sugammadex 1 mg/kg Group

Intervention Type DRUG

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

Sugammadex 2 mg/kg Group (S2)

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

Group Type EXPERIMENTAL

Sugammadex 2 mg/kg Group

Intervention Type DRUG

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

Sugammadex 4 mg/kg Group (S4)

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

Group Type EXPERIMENTAL

Sugammadex 4 mg/kg Group

Intervention Type DRUG

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

Pyridostigmine/Glycopyrrolate Group (PG)

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

Group Type ACTIVE_COMPARATOR

Pyridostigmine/Glycopyrrolate Group

Intervention Type DRUG

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

Interventions

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Sugammadex 1 mg/kg Group

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

Intervention Type DRUG

Sugammadex 2 mg/kg Group

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

Intervention Type DRUG

Sugammadex 4 mg/kg Group

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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S1 S2 S4 PG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes