- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05632107
Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor
March 30, 2026 updated by: Hua Zheng, Huazhong University of Science and Technology
Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor:a Pilot Study
A quantitative neuromuscular monitoring device is desirable to titrate the depth of neuromuscular block (NMB) during a procedure, and to prevent residual effects after removal of the endotracheal tube.
Unfortunately, the most widely used monitoring technique acceleromyography (AMG) typically implies a series of cumbersome installation and calibration procedures that frequently precludes correct use of these devices in clinical practice.
Electromyography (EMG) has recently attracted a lot of attention as an alternative strategy to compensate for the deficiency of AMG-based neuromuscular monitors.
Nowadays, a new technology that allows for the simultaneous acquisition of EMG and AMG signals is commercially available.
Although its reliability has been rapidly accepted in Physical Medicine and Rehabilitation, the use of the technique in neuromuscular monitoring has never been reported.
The aim of the present study is to assess the validity of the new device for estimating the neuromuscular block by comparing with TOF Watch®-SX, which is the most widely accepted AMG-based neuromuscular monitor that has been practiced in the clinical arena for decades.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hua Zheng, Dr.
- Phone Number: 0086-27-83663173
- Email: hzheng@hust.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Hua Zheng, Dr
- Phone Number: +86 18672750530
- Email: hzheng@hust.edu.cn
-
Wuhan, Hubei, China, 430030
- Recruiting
- Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Hua Zheng, Dr.
- Phone Number: 0086-27-83663173
- Email: hzheng@hust.edu.cn
-
Sub-Investigator:
- Yan Fang, Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who need to be treated surgically under general anesthesia and are going to receive neuromuscular blocking agents.
Description
Inclusion Criteria:
- Age less than 18 yr
- American Society of Anesthesiologists Physical Status I to III
- Elective surgery requiring muscle relaxation
- Patients participated voluntarily and signed informed consent
Exclusion Criteria:
- Patients with known neuromuscular disorder
- Stroke
- Patients with a history of allergic reaction toneuromuscular blocking agents
- Use of medications that might interfere with neuromuscular transmission
- Any previous injury to the examined arm that might influence nerve conduction parameters
- Pacemaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessing the correlation between the train-of-four (TOF) obtained from the 2 devices
Time Frame: Perioperative data
|
Perioperative data
|
|
Assessing the correlation between the posttetanic count (PTC) obtained from the 2 devices
Time Frame: Perioperative data
|
Perioperative data
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Screening for eligible individual signal sources from the multiplex information of the new technology for improving neuromuscular monitoring
Time Frame: Perioperative data
|
Perioperative data
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hua Zheng, Dr., Department of Anesthesiology, Tongji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
November 20, 2022
First Submitted That Met QC Criteria
November 20, 2022
First Posted (Actual)
November 30, 2022
Study Record Updates
Last Update Posted (Actual)
April 3, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJMZK202201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.