Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sugammadex 1 mg/kg Group, Sugammadex 2 mg/kg Group, Sugammadex 4 mg/kg Group, Pyridostigmine/Glycopyrrolate Group.
- Who it may be relevant to
- Registry conditions: Neuromuscular Blockade Reversal Agent, Perioperative Complications, Anesthesia, General, Sugammadex. Basic parameters: 19 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Randomized, Double-Blind Study of the Incidence, Severity, and Risk Factors of Clenching Induced by Sugammadex During Neuromuscular Blockade Reversal
Overview
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.
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 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."
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.
Primary outcome measures
- Incidence of Mouth Clenching After Neuromuscular Blockade Reversal [Time frame: Within 10 minutes after administration of neuromuscular blockade reversal agent]
Secondary outcome measures (5)
- Severity of Mouth Clenching [Time frame: Within 10 minutes after reversal agent administration]
- Time to Recovery of Train-of-Four (TOF) Ratio ≥0.9 [Time frame: Up to 10 minutes after administration]
- Bispectral Index (BIS) at Clenching Onset [Time frame: At time of clenching event, within 10 minutes post-reversal]
- Peak Airway Pressure [Time frame: Within 10 minutes post-reversal]
- Incidence of Clenching-Related Complications [Time frame: Within 10 minutes post-reversal]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Wonkwang University hospital — Iksan
Publications
- Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763. PMID 28806470
- Naguib M. Sugammadex: another milestone in clinical neuromuscular pharmacology. Anesth Analg. 2007 Mar;104(3):575-81. doi: 10.1213/01.ane.0000244594.63318.fc. PMID 17312211
- Lee HY, Jung KT. Advantages and pitfalls of clinical application of sugammadex. Anesth Pain Med (Seoul). 2020 Jul 31;15(3):259-268. doi: 10.17085/apm.19099. PMID 33329823
- Lee S, Chung W. Sugammadex for our little ones: a brief narrative review. Anesth Pain Med (Seoul). 2024 Oct;19(4):269-279. doi: 10.17085/apm.24092. Epub 2024 Oct 31. PMID 39512049
- Tsur A, Kalansky A. Hypersensitivity associated with sugammadex administration: a systematic review. Anaesthesia. 2014 Nov;69(11):1251-7. doi: 10.1111/anae.12736. Epub 2014 May 22. PMID 24848211
Identifiers
NCT: NCT06962007 · Wonkwang UH17