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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04381637

Acronym

NIPESTIM

Enrollment

Registered

2020-05-11

Start date

2021-01-28

Completion date

2021-06-10

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Monitoring, General anesthesia, Analgesia, Pain, Pediatric

Brief summary

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.

Interventions

DEVICENIPE 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.

PROCEDURETetanic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

6 Years to 10 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Variation of NIPE index (∆NIPE)	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.

Secondary

Measure	Time frame	Description
Heart rate Variation (∆HR)	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026