Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor

Neuromuscular Blockade Clinical Trial

Official title:

Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor：a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632107
• Other study ID #: TJMZK202201
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Huazhong University of Science and Technology
• Contact: Hua Zheng, Dr.
• Phone: 0086-27-83663173
• Email: hzheng[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• TOF-Watch®;DELSYS® Wireless surface EMG
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.

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the correlation between the train-of-four (TOF) obtained from the 2 devices		Perioperative data
Primary	Assessing the correlation between the posttetanic count (PTC) obtained from the 2 devices		Perioperative data
Secondary	Screening for eligible individual signal sources from the multiplex information of the new technology for improving neuromuscular monitoring		Perioperative data