ClinicalTrials.Veeva

Menu

Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings (EMGvsMMG)

U

University of Debrecen

Status

Completed

Conditions

Patients Undergoing General Anesthesia

Treatments

Device: Mechanomiograph: The "gold standard" of quantitative monitoring
Device: Electromiograph

Study type

Observational

Funder types

Other

Identifiers

NCT06792058
AITT 2023/10

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

20 surgical patients
Description:
20 patients undergoing surgical procedures and receiving muscle relaxation
Treatment:
Device: Electromiograph
Device: Mechanomiograph: The "gold standard" of quantitative monitoring

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems