NCT02892045

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

August 29, 2016

Last Update Submit

June 20, 2019

Conditions

Neuromuscular Blockade

Keywords

neuromuscular blockmonitoring

Outcome Measures

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

    this will determine the Sensitivity and specificity versus MMG mechanomyography

    one year

Secondary Outcomes (1)

  • Bland and Altman bias and limits of agreement

    one year

Study Arms (2)

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

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

Interventions

MMGDEVICE

neuromuscular monitoring device

MMG versus Mindray NMT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sarajevo medical University

Sarajevo, Bosnia and Herzegovina

Location

Dalian Medical University

Dalian, Dalian, 8046, China

Location

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

    PMID: 8904261BACKGROUND

Study Officials

  • Ashraf Dahaba, MD

    Suez Canal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 8, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

BO(1)CN(1)