Clinical trial NCT06792058: Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings
Official title: Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing General Anesthesia
Keywords: Neuromuscular monitoring
MMG
EMG
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing general surgery

Brief summary: Background: Neuromuscular monitoring plays a critical role in reducing postoperative residual neuromuscular blockade (PRNB), a significant risk factor for respiratory complications. Despite the availability of various monitoring techniques, the validation of newer devices remains an ongoing challenge. This study compares the performance of the electromyography (EMG)-based Tetragraph neuromuscular monitor with the gold standard mechanomyography (MMG) device, focusing on their accuracy and reliability in clinical settings.

Methods: Twenty cases were conducted during general surgeries requiring neuromuscular relaxation. Ulnar nerve was stimulated via the Tetragraph which detected the compound muscle action potential (CMAP) of adductor pollicis muscle. Simultaneously on the same arm the isometric force of the same stimulated muscle was registrated by the MMG and displayed in the Labchart 8 program. Bland-Altman analysis was used to describe the agreement between devices during distinct phases of neuromuscular blockade. The primary endpoint of the study was the comparison of TOF values of MMG and EMG during induction. In recovery, two groups were made from TOFRs: below and above the recommended muscle recovery to exclude PRNB (TOFR≥90%) (Fuchs-Buder 2023). Additionally, in deeper neuromuscular blockade Train-of-Four Count (TOFC), and Post-Tetanic Count (PTC) values were also analysed.


Eligibility criteria: Inclusion Criteria:

* Age 18 or over.
* ASA (American Society of Anesthesiology) physical status I-III.
* Informed written consent.
* Surgery requires the use of a moderate-duration muscle relaxant.

Exclusion Criteria:

* History of neuromuscular disease (e.g. stroke with hemi symptoms, myasthenia gravis, severe polyneuropathy).
* Medication affecting neuromuscular transmission.
* Open wound or rash due to electrode position
* Expected difficult intubation.
* Pregnancy, breast-feeding.
* Implanted pacemaker

Primary outcomes:
measure: concordance of the two devices
timeFrame: Intraoperativ
Secondary outcomes:
Other outcomes:
Locations:
city: Debrecen
country: Hungary
facility: University of Debrecen, Department of Anesthesiology and Intensive Care
state: Hajdú-Bihar
Study officials:
affiliation: University of Debrecen, Faculty of Medicine, Department of Anaesthesiology and Intensive Care
name: László Asztalos, PhD
role: STUDY_DIRECTOR
References:
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