- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02880787
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Thomas FUCHS-BUDER, Pr
- Email: t.fuchs-buder@chru-nancy.fr
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00540-47
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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