Mindray Neuromuscular Transmission Transducer

NCT ID: NCT02892045

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Neuromuscular Blockade

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MMG

Intervention Type DEVICE

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

No interventions assigned to this group

Interventions

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MMG

neuromuscular monitoring device

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalian Medical University

OTHER

Sponsor Role collaborator

Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Ashraf Dahaba, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashraf Dahaba, MD

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Locations

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Sarajevo medical University

Sarajevo, , Bosnia and Herzegovina

Site Status

Dalian Medical University

Dalian, Dalian, China

Site Status

Countries

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Bosnia and Herzegovina China

References

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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. doi: 10.1111/j.1399-6576.1996.tb04389.x.

Reference Type BACKGROUND
PMID: 8904261 (View on PubMed)

Other Identifiers

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NMT1

Identifier Type: -

Identifier Source: org_study_id

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