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Mindray Neuromuscular Transmission Transducer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02892045
Acronym
NMT1
Enrollment
48
Registered
2016-09-08
Start date
2016-09-30
Completion date
2017-09-30
Last updated
2019-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

neuromuscular block, monitoring

Brief summary

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.

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.

Interventions

DEVICEMMG

neuromuscular monitoring device

Sponsors

Dalian Medical University
CollaboratorOTHER
Suez Canal University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pharmacodynamics parameters (onset time 95% maximum depression, clinical duration T1 25%, and full recovery 0.8-0.9 TOF ratio neuromuscular blockone yearthis will determine the Sensitivity and specificity versus MMG mechanomyography

Secondary

MeasureTime frameDescription
Bland and Altman bias and limits of agreementone yearBias is difference between the 2 monitors and the limits of agreement is bias +/- 1.96 SD.

Countries

Bosnia and Herzegovina, China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026