A Comparative Study of the Next-Generation TetraGraph® and Mechanomyography Neuromuscular Monitors in Clinical Settings

Official title

Comparative Clinical Evaluation of the Next-Generation TetraGraph® and Mechanomyography for Quantitative Neuromuscular Monitoring

Overview

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 New Generation 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

• Device Mechanomiograph
  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.
• Device Electromiograph
  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 the

Primary outcome measures

• concordance between the two devices. [Time frame: intraoperative]

Eligibility criteria

Inclusion criteria

• Age 18 years or older.
• ASA (American Society of Anesthesiology) physical status I-III.
• Written informed consent.
• The use of a medium-acting muscle relaxant is required for the surgery.

Exclusion criteria

• History of neuromuscular disease (e.g., stroke with hemiplegic symptoms, myasthenia gravis, severe polyneuropathy).
• Use of medications affecting neuromuscular transmission.
• Open wound or rash in the area corresponding to the electrode placement.
• Anticipated difficult intubation.
• Pregnancy, breastfeeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Hungary · 1 center

• University of Debrecen, Department of Anesthesiology and Intensive Care — Debrecen

Publications

• Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x. PMID 17635389
• Ebert TJ, Vogt JA, Kaur R, Iqbal Z, Peters DJ, Cummings CE, Stekiel TA. Train-of-four ratio, counts and post tetanic counts with the Tetragraph electromyograph in comparison to mechanomyography. J Clin Monit Comput. 2025 Feb;39(1):149-156. doi: 10.1007/s10877-024-01225-3. Epub 2024 Oct 18. PMID 39424740
• Sato H, Iwasaki H, Doshu-Kajiura A, Katagiri S, Takagi S, Luthe SK, Suzuki T. Comparison of two electromyography-based neuromuscular monitors, AF-201P and TetraGraph, in rocuronium-induced neuromuscular block: A prospective comparative study. Anaesth Crit Care Pain Med. 2022 Dec;41(6):101145. doi: 10.1016/j.accpm.2022.101145. Epub 2022 Aug 31. PMID 36057386
• Nemes R, Lengyel S, Nagy G, Hampton DR, Gray M, Renew JR, Tassonyi E, Fulesdi B, Brull SJ. Ipsilateral and Simultaneous Comparison of Responses from Acceleromyography- and Electromyography-based Neuromuscular Monitors. Anesthesiology. 2021 Oct 1;135(4):597-611. doi: 10.1097/ALN.0000000000003896. PMID 34329371
• Kopman AF, Justo MD, Mallhi MU, Abara CE, Neuman GG. The influence of changes in hand temperature on the indirectly evoked electromyogram of the first dorsal interosseous muscle. Can J Anaesth. 1995 Dec;42(12):1090-5. doi: 10.1007/BF03015094. PMID 8595683
• Engbaek J, Skovgaard LT, Friis B, Kann T, Viby-Mogensen J. Monitoring of the neuromuscular transmission by electromyography (I). Stability and temperature dependence of evoked EMG response compared to mechanical twitch recordings in the cat. Acta Anaesthesiol Scand. 1992 Aug;36(6):495-504. doi: 10.1111/j.1399-6576.1992.tb03506.x. PMID 1325093
• Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738. PMID 28044330
• Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386. PMID 17307778

Identifiers

NCT: NCT07750405 · AITT 2026/2 · BM/13493-3/2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗