Patients Undergoing General Anesthesia
Conditions
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 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
DEVICEMechanomiograph
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.
DEVICEElectromiograph
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
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| concordance between the two devices. | intraoperative | The primary endpoint of the study is to compare TOF values measured using mechanomyography and electromyography, and to assess the measurement concordance between the two devices. |
Countries
Hungary
Contacts
CONTACTBéla Fülesdi, MD
CONTACTErzsébet Igbonu-Nagy
STUDY_DIRECTORLászló Asztalos, MD
University of Debrecen, Department of Anesthesiology and Intensive Care
PRINCIPAL_INVESTIGATORLászló Asztalos, MD
University of Debrecen, Department of Anesthesiology and Intensive Care
Outcome results
None listed