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

August 23, 2016 updated by: Central Hospital, Nancy, France

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%.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Vandoeuvre Les Nancy, France
        • Recruiting
        • CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adult population:

  • Non opposition to research
  • > 18 years old
  • ASA score 1-3
  • Undergoing surgery with curarisation through tracheal intubation
  • Affiliation to social security

Pediatric population:

  • > 1 year old
  • Non opposition to research of child (if able to consent) or representatives with parental authority
  • ASA score 1-4
  • Undergoing surgery with curarisation
  • Affiliation to social security

Exclusion Criteria:

Adult population:

  • Allergy to administered drugs
  • Known or suspected difficult intubation
  • Pregnant women
  • BMI > 40

Pediatric population:

  • Allergy to administered drugs
  • Known or suspected difficult intubation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Adult population 1
TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
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)
Each monitor on one arm
OTHER: Adult population 2
TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
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)
Each monitor on one arm
OTHER: Pediatric population 1
TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
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)
Each monitor on one arm
OTHER: Pediatric population 2
TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
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)
Each monitor on one arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia
Time of recovery of the second (T2) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia
Time of recovery of the third (T3) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia
Time of recovery of the fourth (T4) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 40% of initial value displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 60% of initial value displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 90% of initial value displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 100% of initial value displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of suppression of the first response of train of four monitoring (T1) at 95% initial value displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia
Time of recovery of the first response of train of four monitoring (T1) to 25% initial value displayed on TOFScan and on TOF Watch SX
Time Frame: day 0, after induction of anesthesia
day 0, after induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (ESTIMATE)

August 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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