Mindray Neuromuscular Transmission Transducer (NMT1)

June 20, 2019 updated by: Ashraf Dahaba, MD, Suez Canal University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina
        • Sarajevo medical University
  • China
    • Dalian
      • Dalian, Dalian, China, 8046
        • Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MMG versus Mindray NMT
24 patients where Mindray NMT is monitoring one hand versus Mechanomyograph on the other hand accessible in supine position, alternately right and left hands monitoring neuromuscular block of rocuronium neuromuscular blocking agent 0.6 mg/kg.
Device: MMG
neuromuscular monitoring device
TOFWatch versus Mindray NMT
24 patients where Mindray NMT is monitoring one hand versus TOF-Watch Acceleromyograph on the other hand accessible in supine position, alternately right and left hands monitoring neuromuscular block of rocuronium neuromuscular blocking agent 0.6 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Collaborators

Dalian Medical University

Investigators

  • Principal Investigator: Ashraf Dahaba, MD, Suez Canal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NMT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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