Neuromuscular Blockade Reversal AgentNCT06962007
Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal
A study testing Sugammadex 1 mg/kg Group, Sugammadex 2 mg/kg Group and Sugammadex 4 mg/kg Group in people with Neuromuscular Blockade Reversal Agent and Perioperative Complications, run by Wonkwang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade Reversal Agent, Perioperative Complications, Anesthesia, General
- What is being tested?
- Sugammadex 1 mg/kg Group, Sugammadex 2 mg/kg Group and Sugammadex 4 mg/kg Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2025to 14 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Wonkwang University hospital
Iksan, Jeonbuk-do, 54538
Cheolhyeong LEE, MD, 82-10-7736-9397, Leecheolhyeong@gmail.com
About this study
Official title: A Prospective, Randomized, Double-Blind Study of the Incidence, Severity, and Risk Factors of Clenching Induced by Sugammadex During Neuromuscular Blockade Reversal
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.
Read more
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.
Read the 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."
- Conditions
- Neuromuscular Blockade Reversal Agent, Perioperative Complications, Anesthesia, General, Sugammadex, Monitoring, Intraoperative, Masseter Muscle Spasm
- Being tested
- Sugammadex 1 mg/kg Group, Sugammadex 2 mg/kg Group, Sugammadex 4 mg/kg Group, Pyridostigmine/Glycopyrrolate Group
- Keywords
- sugammadex, mouth clenching, neuromuscular blockade reversal
- Medical subject headings
- Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 1 mg/kg GroupDrug
Also called S1
Participants receive 1 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
Sugammadex 2 mg/kg GroupDrug
Also called S2
Participants receive 2 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
Sugammadex 4 mg/kg GroupDrug
Also called S4
Participants receive 4 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
Pyridostigmine/Glycopyrrolate GroupDrug
Also called PG
Participants receive pyridostigmine 0.2 mg/kg and glycopyrrolate 0.01 mg/kg intravenously for reversal of rocuronium-induced neuromuscular blockade.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex 1 mg/kg Group (S1) | Experimental | Participants receive 1 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Pyridostigmine/Glycopyrrolate Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 10 minutes after administration of neuromuscular blockade reversal agent
Secondary outcomes (5)
Severity of Mouth Clenching
Graded using a novel five-grade severity scale based on degree of jaw closure, EMG intensity, airway pressure, and need for intervention.
Measured: Within 10 minutes after reversal agent administration
Time to Recovery of Train-of-Four (TOF) Ratio ≥0.9
Measured using peripheral nerve stimulator; defined as time from reversal agent injection to TOF ratio ≥0.9.
Measured: Up to 10 minutes after administration
Bispectral Index (BIS) at Clenching Onset
BIS value recorded at the time clenching is first detected.
Measured: At time of clenching event, within 10 minutes post-reversal
Peak Airway Pressure
Maximum airway pressure measured within 10 minutes after administration of reversal agent.
Measured: Within 10 minutes post-reversal
Incidence of Clenching-Related Complications
Incidents such as bite injury, airway obstruction, or need for additional airway intervention during or after reversal.
Measured: Within 10 minutes post-reversal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Jul 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Blockade Reversal AgentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee,MD,PhD,, Wonkwang University Hospital
- Investigators
- Cheolhyeong Lee, MD, Principal investigator, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962007
- Sponsor's protocol ID
- Wonkwang UH17
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this article will be shared, including study protocol, statistical analysis plan, and analytic code.
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.
PubMed 28806470Naguib M. Sugammadex: another milestone in clinical neuromuscular pharmacology. Anesth Analg. 2007 Mar;104(3):575-81. doi: 10.1213/01.ane.0000244594.63318.fc.
PubMed 17312211Lee 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.
PubMed 33329823Lee 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.
PubMed 39512049Tsur 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.
PubMed 24848211
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind Study of the Incidence, Severity, and Risk Factors of Clenching Induced by Sugammadex During Neuromuscular Blockade Reversal
- ClinicalTrials.gov ID
- NCT06962007
- Acronym / sponsor ID
- Wonkwang UH17
- Conditions
- Neuromuscular Blockade Reversal Agent, Perioperative Complications, Anesthesia, General, Sugammadex, Monitoring, Intraoperative, Masseter Muscle Spasm
- Keywords
- sugammadex, mouth clenching, neuromuscular blockade reversal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sugammadex 1 mg/kg Group (S1) | Experimental | Drug: Sugammadex 1 mg/kg GroupParticipants receive 1 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade. |
| Sugammadex 2 mg/kg Group (S2) | Experimental | Drug: Sugammadex 2 mg/kg GroupParticipants receive 2 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade. |
| Sugammadex 4 mg/kg Group (S4) | Experimental | Drug: Sugammadex 4 mg/kg GroupParticipants receive 4 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade. |
| Pyridostigmine/Glycopyrrolate Group (PG) | Active comparator | Drug: Pyridostigmine/Glycopyrrolate GroupParticipants receive pyridostigmine 0.2 mg/kg and glycopyrrolate 0.01 mg/kg intravenously for reversal of rocuronium-induced neuromuscular blockade. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadex 1 mg/kg GroupAlso: S1Participants receive 1 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade. | Drug | Sugammadex 1 mg/kg Group (S1) |
| Sugammadex 2 mg/kg GroupAlso: S2Participants receive 2 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade. | Drug | Sugammadex 2 mg/kg Group (S2) |
| Sugammadex 4 mg/kg GroupAlso: S4Participants receive 4 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade. | Drug | Sugammadex 4 mg/kg Group (S4) |
| Pyridostigmine/Glycopyrrolate GroupAlso: PGParticipants receive pyridostigmine 0.2 mg/kg and glycopyrrolate 0.01 mg/kg intravenously for reversal of rocuronium-induced neuromuscular blockade. | Drug | Pyridostigmine/Glycopyrrolate Group (PG) |
Primary outcome
Incidence of Mouth Clenching After Neuromuscular Blockade Reversal
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 28806470Hristovska 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.
- Background: PubMed 17312211Naguib M. Sugammadex: another milestone in clinical neuromuscular pharmacology. Anesth Analg. 2007 Mar;104(3):575-81. doi: 10.1213/01.ane.0000244594.63318.fc.
- Background: PubMed 33329823Lee 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.
- Background: PubMed 39512049Lee 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.
- Background: PubMed 24848211Tsur 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this article will be shared, including study protocol, statistical analysis plan, and analytic code.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheolhyeong Lee, MD principal investigator
Wonkwang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex 1 mg/kg Group, Sugammadex 2 mg/kg Group and Sugammadex 4 mg/kg Group in people with Neuromuscular Blockade Reversal Agent and Perioperative Complications, run by Wonkwang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheol Lee, MD, PhD (82-10-6613-1252, ironyii70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Mouth Clenching After Neuromuscular Blockade Reversal (time frame: Within 10 minutes after administration of neuromuscular blockade reversal agent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06962007, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.