Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia (NIPESTIM)
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|ClinicalTrials.gov Identifier: NCT04381637|
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : March 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Device: NIPE monitor Procedure: Tetanic stimulations||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The research does not involve the evaluation or comparison of medical strategies.The order of application of the stimuli will be randomized according to a Latin square of order 3.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 28, 2021|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
Device: NIPE monitor
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.
Procedure: Tetanic stimulations
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381637
|Contact: Anne LAFFARGUE, MD||0320445741 ext +email@example.com|
|Hopital Roger Salengro, CHU Lille||Recruiting|
|Lille, France, 59037|
|Principal Investigator:||Anne LAFFARGUE, MD||University Hospital, Lille|