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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: NIPE monitor; Procedure: Tetanic stimulations

• Registration Number: NCT04381637
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-11
• Study Start: 2021-01-28
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIPE	NIPE monitor	-
NIPE	Tetanic stimulations	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hopital Roger Salengro, CHU Lille; 🇫🇷 Lille, France