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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-28

Study Completion Date

2021-06-10

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.

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NIPE

Group Type EXPERIMENTAL

NIPE monitor

Intervention Type DEVICE

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.

Tetanic stimulations

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No