Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings

Completed

• Conditions: Patients Undergoing General Anesthesia

• Registration Number: NCT06792058
• Lead Sponsor: University of Debrecen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-19
• Last Update Submitted: 2025-01-19
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
concordance of the two devices	Intraoperativ	The primary endpoint of the study is the comparison of TOF values measured by mechanomyography and electromyography, and the examination of the measurement concordance of the two devices.

Trial Locations

Locations (1)

University of Debrecen, Department of Anesthesiology and Intensive Care; 🇭🇺 Debrecen, Hajdú-Bihar, Hungary