跳至主要内容
临床试验/NCT07750405
NCT07750405尚未招募不适用

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

University of Debrecen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
concordance between the two devices.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

20 surgical patients

undergoing surgical procedures and receiving muscle relaxation

干预措施: Mechanomiograph (Device)

20 surgical patients

undergoing surgical procedures and receiving muscle relaxation

干预措施: Electromiograph (Device)

结局指标

主要结局

concordance between the two devices.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pongrácz Adrienn

MD, PhD

University of Debrecen

研究点 (1)

Loading locations...

相似试验