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Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings

Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06792058
Acronym
EMGvsMMG
Enrollment
20
Registered
2025-01-24
Start date
2024-01-02
Completion date
2024-12-31
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing General Anesthesia

Keywords

Neuromuscular monitoring, MMG, EMG

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.

Interventions

DEVICEMechanomiograph: The gold standard of quantitative monitoring

The gold standard of quantitative monitoring is mechanomyography (MMG), which measures the force of contraction of the adductor pollicis muscle following ulnar nerve stimulation. MMG responses are accurate and reproducible. However, the complex and bulky devices are only suitable for research use, are not suitable for clinical use and are not commercially available.

Another type of monitor is the electromyograph, which can be seen as an alternative to mechanomyography because of its accuracy. This technique measures muscle activity as a summation of the action potentials of muscle fibres. This activity is proportional to the strength of the muscle contraction. The most commonly innervated nerve is also the ulnar nerve, which innervates the abductor digiti minimi and the first dorsalis interosseus muscles. During the measurements, electrical signals from these muscles are detected. EMG has several advantages over other monitoring techniques. It does not require immobilisation of the hand, thumb immobility is not a problem, no preload is required, and hypothermia does not affect the hand as much as other neuromuscular monitors. The TetraGraph (Senzime AB, Sweden) is a portable EMG-based neuromuscular minitor for which the manufacturers received marketing approval from the U.S. Food and Drug Administration (FDA) in 2019.

Sponsors

University of Debrecen
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
concordance of the two devicesIntraoperativThe 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.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026