- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04381637
Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia (NIPESTIM)
Newborn Infant Parasympathetic Evaluation (NIPE) Index After Three Standardized Tetanic Stimulations (10, 30 and 60 Miliamps) Performed in a Randomized Sequence Under General Anesthesia in a Pediatric Population
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France, 59037
- Hôpital Roger Salengro, CHU Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
- Written informed consent obtained from parents (and from child if appropriate)
Exclusion Criteria:
- Thoracic or cardiac surgery
- Cardiac arrhythmia, Pace maker
- Analgesic medication less than 24 hours before surgery
- Chronic anticholinergic medication
- Contraindication to muscle relaxants or general anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NIPE
|
NIPE monitor connected to the anesthetic station.
No part of the device in contact with the patient.
No action on patient or anesthesia.
Automatic recording of Heart rate and NIPE index during the study period.
Three tetanic stimulations will be performed (10-30 and 60 milliamps) under general anesthesia, before surgical incision. Stims performed via the muscle relaxation monitor (used in standard practice in this population) Each stim lasts for 5 seconds. Interval between two stims : 3-5 minutes Order on intensities randomized by a latin square of order 3. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of NIPE index (∆NIPE)
Time Frame: 3 minutes following tetanic stimulation
|
∆NIPE = [NIPE minimal value in the 3 minutes following the stim] - [NIPE before stim] NIPE varies from 0 to 100. Monitor displays one value per second. NIPE index expected to decrease after stim. |
3 minutes following tetanic stimulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate Variation (∆HR)
Time Frame: 3 minutes following tetanic stimulation
|
∆HR = [HR maximal value in the 3 minutes following the stim] - [HR before stim] Heart rate expected to increase after stim.
|
3 minutes following tetanic stimulation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne LAFFARGUE, MD, University Hospital, Lille
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019_32
- 2020-A00295-34 (Other Identifier: ID-RCB number,ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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