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

Anesthesia Clinical Trial

— NIPESTIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381637
• Other study ID #: 2019_32
• Secondary ID: 2020-A00295-34
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: June 10, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Fondation Apicil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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