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

NCT04381637 | Completed

• 2 other identifiers: 2019_322020-A00295-34
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Monitoring; General anesthesia; Analgesia; Pain; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart rate Variation (∆HR)

  3 minutes following tetanic stimulation

Study Arms (1)

NIPE

EXPERIMENTAL

Device: NIPE monitor; Procedure: Tetanic stimulations

Interventions

NIPE monitor 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.

NIPE

Tetanic stimulations 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.

NIPE

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
• Written informed consent obtained from parents (and from child if appropriate)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Fondation Apicil: collaborator

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

Related Publications (1)

• Lebrun S, Boccara J, Cailliau E, Herbet M, Tavernier B, Constant I, Sabourdin N. Quantitative assessment of a pediatric nociception monitor in children under sevoflurane anesthesia. Reg Anesth Pain Med. 2022 Jun 2:rapm-2022-103547. doi: 10.1136/rapm-2022-103547. Online ahead of print.

  PMID: 35654480 DERIVED

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne LAFFARGUE, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: January 28, 2021
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

FR (1)