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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381637
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : March 15, 2021
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: NIPE monitor Procedure: Tetanic stimulations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: NIPE 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.





Primary Outcome Measures :
  1. Variation of NIPE index (∆NIPE) [ Time Frame: 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 :
  1. Heart rate Variation (∆HR) [ Time Frame: 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.



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381637


Contacts
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Contact: Anne LAFFARGUE, MD 0320445741 ext +33 anne.laffargue@chru-lille.fr

Locations
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France
Hopital Roger Salengro, CHU Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Sponsors and Collaborators
University Hospital, Lille
Fondation Apicil
Investigators
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Principal Investigator: Anne LAFFARGUE, MD University Hospital, Lille
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04381637    
Other Study ID Numbers: 2019_32
2020-A00295-34 ( Other Identifier: ID-RCB number,ANSM )
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Monitoring
General anesthesia
Analgesia
Pain
Pediatric