Neuromuscular BlockadeNCT05632107
Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor
An observational study of Neuromuscular Blockade, run by Huazhong University of Science and Technology at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- TOF-Watch®；DELSYS® Wireless surface EMG
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2023to Dec 2027
- Phase
- Observational
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who need to be treated surgically under general anesthesia and are going to receive neuromuscular blocking agents.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Hua Zheng, Dr., 0086-27-83663173, hzheng@hust.edu.cn
Yan Fang, Dr.
- Recruiting
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Hua Zheng, Dr, +86 18672750530, hzheng@hust.edu.cn
About this study
Official title: 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.
- Conditions
- Neuromuscular Blockade
- Being tested
- TOF-Watch®；DELSYS® Wireless surface EMG
- Keywords
- neuromuscular blocking agents; residual neuromuscular blockade; neuromuscular monitoring; acceleromyography; electromyography
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF-Watch®；DELSYS® Wireless surface EMGDevice
TOF-Watch® is the most widely accepted AMG-based neuromuscular monitor; and DELSYS® Wireless surface EMG is a new technology that allows for the simultaneous acquisition of EMG and AMG signals in a wireless manner.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the correlation between the train-of-four (TOF) obtained from the 2 devices
Measured: Perioperative data
Assessing the correlation between the posttetanic count (PTC) obtained from the 2 devices
Measured: Perioperative data
Secondary outcomes (1)
Screening for eligible individual signal sources from the multiplex information of the new technology for improving neuromuscular monitoring
Measured: Perioperative data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zheng, Huazhong University of Science and Technology
- Investigators
- Hua Zheng, Dr., Study director, Department of Anesthesiology, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632107
- Sponsor's protocol ID
- TJMZK202201
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No