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OpenTrials
Completed

NCT Number: NCT04432480

NIPE Monitoring Values During Routine Pediatric Anesthesia

Description of the standard values and fluctuations of the new NIPE index during routine pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous value ranging from 0 to 100. NIPE values described at different time points during anesthesia: beginning of induction, intubation, extubation, skin incision, opioid administration, vasopressors or atropine administration, transfusion, volume expansion. In addition, NIPE values during hemodynamic events (heart rate or blood pressure increase greater than 20%) will be recorded.

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Key information

Conditions

Anesthesia Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgery under general anesthesia
  • Absence of analgesic treatment in the 24 hours before the intervention

Exclusion criteria

  • Central or peripheral neuropathy
  • Non sinus arrythmia, pace maker
  • Cardiac surgery
  • Analgesic medication within 24 hours before surgery
  • Anti cholinergic or anti arrythmic chronic medication
  • Opposition of the legal tutor or of the child

Treatment and study plan

NIPE (Newborn Infant Parasympathetic Evaluation) monitoring

Procedure

Non invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia.

Primary outcomes

  1. Variation of the instantaneous NIPE index after opioid administration

    Time frame: 5 minutes after opioid administration

Secondary outcomes

  1. the area under the ROC curve of NIPE value

    Time frame: Baseline and 5 minutes before the first hemodynamic event.

    the NIPE value is definied by the predictibility of a hemodynamic event : 20% increase in Baseline heart rate, blood pressure and NIPE values recorded just before skin incision

  2. Variation of the instantaneous NIPE index after skin incision

    Time frame: 5 minutes after skin incision

  3. Variation of the instantaneous NIPE index after insertion of airway control device

    Time frame: 5 minutes after insertion of airway control device

  4. Variation of the instantaneous NIPE index after removal of airway control device

    Time frame: 5 minutes after removal of airway control device

  5. Variation of the instantaneous NIPE index after anesthetic induction

    Time frame: 5 minutes after anesthetic induction

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Fondation Apicil

Registry information

Official study title

Parasympathetic Activity Evaluation by Newborn Infant Parasympathetic Evaluation (NIPE) Monitor (MDMSTM, Loos, France) During Routine General Anesthesia in Children

Acronym: OMNIPED

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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