Skip to main content
OpenTrials
Completed

NCT Number: NCT02892045

Mindray Neuromuscular Transmission Transducer

A new NMT module from Mindray (Mindray Co. Shenzhen, People's Republic of China.) claims to measure 3 directional accelerography. The aim of the study is to compare the neuromuscular block of rocuronium 0.6 mg/kg (twice the 95% effective dose, ED95) monitored by the NMT versus that monitored by the Relaxometer Mechanomyograph on the other hand in Group 1, and versus the TOF-Watch on the other hand in Group 2 to clinically evaluate the new system for its diagnostic accuracy.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Sarajevo medical University, Sarajevo, Bosnia and Herzegovina

Loading trial locations.

About this study

Mechanomyography (MMG) is regarded as the standard method for precise quantification of neuromuscular block. The conventional MMG measures the exact force of muscle contraction in response to electric stimulation of the ulnar nerve. MMG quantifies the neuromuscular function by measurement of the force displacement. However the equipment is rather bulky, takes time to set up, requires a rigid support of the arm in an often-crowded operating room. This limits its clinical use in the daily anesthesia practice. Acceleromyography is based on the acceleration of a piezo-electrode. A new NMT module from (Shenzhen, People's Republic of China.) claims to measure 3 directional accelerography. The aim of the study is to compare the neuromuscular block of rocuronium 0.6 mg/kg (twice the 95% effective dose, ED95) monitored by the NMT to that monitored by the Relaxometer Mechanomyograph in Group 1, and versus TOF-Watch Acceleromyograph in Group 2 to clinically evaluate the new system for its diagnostic accuracy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 24 patients with Mindray NMT monitoring on one hand versus MMG Mechanomyograph on the other hand in Group 1 with both hands accessible in supine position alternately right and left hands monitoring neuromuscular block of rocuronium neuromuscular blocking agent 0.6 mg/kg
  • 24 patients with Mindray NMT monitoring one hand versus TOF-Watch Acceleromyograph on the other hand in Group 2 with both hands accessible in supine position alternately right and left hands monitoring neuromuscular block of rocuronium neuromuscular blocking agent 0.6 mg/kg.

Exclusion criteria

  • Both hand inaccessible in supine position, patients receiving drugs interfering with rocuronium neuromuscular block, or patients with small joint arthritis that could affect neuromuscular monitoring.

Treatment and study plan

MMG

Device

neuromuscular monitoring device

Primary outcomes

  1. Pharmacodynamics parameters (onset time 95% maximum depression, clinical duration T1 25%, and full recovery 0.8-0.9 TOF ratio neuromuscular block

    Time frame: one year

    this will determine the Sensitivity and specificity versus MMG mechanomyography

Secondary outcomes

  1. Bland and Altman bias and limits of agreement

    Time frame: one year

    Bias is difference between the 2 monitors and the limits of agreement is bias +/- 1.96 SD.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Collaborators

  • Dalian Medical University

Registry information

Official study title

Sensitivity and Specificity of the New Mindray 3-Directional Neuromuscular Transmission Module Versus the Relaxometer Mechanomyograph and Versus TOF-Watch Acceleromyograph for Neuromuscular Block Monitoring

Acronym: NMT1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2016
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.