Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal

NCT06962007 | Completed DMC

• 1 other identifier: Wonkwang UH17
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 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

Keywords

sugammadex; mouth clenching; neuromuscular blockade reversal

Outcome Measures

Primary Outcomes (1)

• Incidence of Mouth Clenching After Neuromuscular Blockade Reversal

  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.

  Within 10 minutes after administration of neuromuscular blockade reversal agent

Secondary Outcomes (5)

• Severity of Mouth Clenching

  Within 10 minutes after reversal agent administration

• Time to Recovery of Train-of-Four (TOF) Ratio ≥0.9

  Up to 10 minutes after administration

• Bispectral Index (BIS) at Clenching Onset

  At time of clenching event, within 10 minutes post-reversal

• Peak Airway Pressure

  Within 10 minutes post-reversal

• Incidence of Clenching-Related Complications

  Within 10 minutes post-reversal

Study Arms (4)

Sugammadex 1 mg/kg Group (S1)

EXPERIMENTAL

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

Drug: Sugammadex 1 mg/kg Group

Sugammadex 2 mg/kg Group (S2)

EXPERIMENTAL

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

Drug: Sugammadex 2 mg/kg Group

Sugammadex 4 mg/kg Group (S4)

EXPERIMENTAL

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

Drug: Sugammadex 4 mg/kg Group

Pyridostigmine/Glycopyrrolate Group (PG)

ACTIVE COMPARATOR

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

Drug: Pyridostigmine/Glycopyrrolate Group

Interventions

Sugammadex 1 mg/kg Group DRUG

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

Also known as: S1

Sugammadex 1 mg/kg Group (S1)

Sugammadex 2 mg/kg Group DRUG

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

Also known as: S2

Sugammadex 2 mg/kg Group (S2)

Sugammadex 4 mg/kg Group DRUG

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

Also known as: S4

Sugammadex 4 mg/kg Group (S4)

Pyridostigmine/Glycopyrrolate Group DRUG

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

Also known as: PG

Pyridostigmine/Glycopyrrolate Group (PG)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwang University hospital

Iksan, Jeonbuk-do, 54538, South Korea

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Trismus

Interventions

Sugammadex; Population Groups; S 1 (combination); Epinephrine; Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Demography; Population Characteristics; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cheolhyeong Lee, MD

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 8, 2025
• Study Start: May 1, 2025
• Primary Completion: May 20, 2025
• Study Completion: July 14, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and agree to sign a data access agreement.

Locations

KR (1)