Comparative Clinical Evaluation of the Next-Generation TetraGraph® and Mechanomyography for Quantitative Neuromuscular Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Debrecen
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- concordance between the two devices.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
20 surgical patients
undergoing surgical procedures and receiving muscle relaxation
Intervention: Mechanomiograph (Device)
20 surgical patients
undergoing surgical procedures and receiving muscle relaxation
Intervention: Electromiograph (Device)
Outcomes
Primary Outcomes
concordance between the two devices.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Pongrácz Adrienn
MD, PhD
University of Debrecen