Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia

Study Overview
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Brief Summary
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NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.

Official Title
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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

Conditions
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Anesthesia

Intervention / Treatment
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* Device: NIPE monitor
* Procedure: Tetanic stimulations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIPE<br> | Device: NIPE monitor<br>* 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.<br>Procedure: Tetanic stimulations<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of NIPE index (∆NIPE) | ∆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) | ∆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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monitoring, General anesthesia, Analgesia, Pain, Pediatric