Clinical trial NCT05632107: Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor
Official title: Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor：a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Blockade
Keywords: neuromuscular blocking agents; residual neuromuscular blockade; neuromuscular monitoring; acceleromyography; electromyography
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who need to be treated surgically under general anesthesia and are going to receive neuromuscular blocking agents.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessing the correlation between the train-of-four (TOF) obtained from the 2 devices
timeFrame: Perioperative data
measure: Assessing the correlation between the posttetanic count (PTC) obtained from the 2 devices
timeFrame: Perioperative data
Secondary outcomes:
measure: Screening for eligible individual signal sources from the multiplex information of the new technology for improving neuromuscular monitoring
timeFrame: Perioperative data
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anesthesiology, Tongji Hospital
name: Hua Zheng, Dr.
role: STUDY_DIRECTOR
References: