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Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®

NCT02880787 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2016-08-26

No results posted yet for this study

Summary

The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population.

Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:

* the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value
* the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value
* recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)
* complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.

Conditions

  • Curarisation
  • Neuromuscular Monitoring

Interventions

DRUG

Rocuronium

Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)

DEVICE

Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

Each monitor on one arm

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Thomas FUCHS-BUDER, Pr · CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation - VANDOEUVRE LES NANCY - FRANCE

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02880787 on ClinicalTrials.gov