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

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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

Tracking Information
First Submitted Date  ICMJE May 6, 2020
First Posted Date  ICMJE May 11, 2020
Last Update Posted Date March 15, 2021
Actual Study Start Date  ICMJE January 28, 2021
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • 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.

Study Arms  ICMJE Experimental: NIPE
Interventions:
  • Device: NIPE monitor
  • Procedure: Tetanic stimulations
Publications * 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. pii: rapm-2022-103547. doi: 10.1136/rapm-2022-103547. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anne LAFFARGUE, MD 0320445741 ext +33 anne.laffargue@chru-lille.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04381637
Other Study ID Numbers  ICMJE 2019_32
2020-A00295-34 ( Other Identifier: ID-RCB number,ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Lille
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Lille
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fondation Apicil
Investigators  ICMJE
Principal Investigator: Anne LAFFARGUE, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP