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

NCT05632107 | Recruiting

• 1 other identifier: TJMZK202201
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neuromuscular Blockade

Keywords

neuromuscular blocking agents; residual neuromuscular blockade; neuromuscular monitoring; acceleromyography; electromyography

Outcome Measures

Primary Outcomes (2)

• Assessing the correlation between the train-of-four (TOF) obtained from the 2 devices

  Perioperative data

• Assessing the correlation between the posttetanic count (PTC) obtained from the 2 devices

  Perioperative data

Secondary Outcomes (1)

• Screening for eligible individual signal sources from the multiplex information of the new technology for improving neuromuscular monitoring

  Perioperative data

Interventions

TOF-Watch®；DELSYS® Wireless surface EMG DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who need to be treated surgically under general anesthesia and are going to receive neuromuscular blocking agents.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (2)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hua Zheng, Dr.

  Department of Anesthesiology, Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Hua Zheng, Dr.

CONTACT

0086-27-83663173; hzheng@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CN (2)