NIPE Monitoring Values During Routine Pediatric Anesthesia

NCT ID: NCT04432480

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-23

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Nociceptive Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children

0-15 years old children undergoing surgery under general anesthesia

NIPE (Newborn Infant Parasympathetic Evaluation) monitoring

Intervention Type PROCEDURE

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

Interventions

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NIPE (Newborn Infant Parasympathetic Evaluation) monitoring

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Apicil

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne LAFFARGUE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2020-A00059-30

Identifier Type: OTHER

Identifier Source: secondary_id

2019_31

Identifier Type: -

Identifier Source: org_study_id

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