Mindray Neuromuscular Transmission Transducer

Neuromuscular Blockade Clinical Trial

— NMT1  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892045
• Other study ID #: NMT1
• Status: Completed
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: June 2019
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• MMG
neuromuscular monitoring device

Locations

Country	Name	City	State
Bosnia and Herzegovina	Sarajevo medical University	Sarajevo
China	Dalian Medical University	Dalian	Dalian

Sponsors (2)

Lead Sponsor	Collaborator
Suez Canal University	Dalian Medical University

Countries where clinical trial is conducted

Bosnia and Herzegovina,  China, 

References & Publications (1)

Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics parameters (onset time 95% maximum depression, clinical duration T1 25%, and full recovery 0.8-0.9 TOF ratio neuromuscular block	this will determine the Sensitivity and specificity versus MMG mechanomyography	one year
Secondary	Bland and Altman bias and limits of agreement	Bias is difference between the 2 monitors and the limits of agreement is bias +/- 1.96 SD.	one year