NIPE Monitoring Values During Routine Pediatric Anesthesia

NCT04432480 | Completed

• 2 other identifiers: 2019_312020-A00059-30
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Nociceptive Pain

Keywords

General anesthesia; Nociceptive Pain; Monitoring; Pediatric anesthesia

Outcome Measures

Primary Outcomes (1)

• Variation of the instantaneous NIPE index after opioid administration

  5 minutes after opioid administration

Secondary Outcomes (5)

• the area under the ROC curve of NIPE value

  Baseline and 5 minutes before the first hemodynamic event.

• Variation of the instantaneous NIPE index after skin incision

  5 minutes after skin incision

• Variation of the instantaneous NIPE index after insertion of airway control device

  5 minutes after insertion of airway control device

• Variation of the instantaneous NIPE index after removal of airway control device

  5 minutes after removal of airway control device

• Variation of the instantaneous NIPE index after anesthetic induction

  5 minutes after anesthetic induction

Study Arms (1)

Children

0-15 years old children undergoing surgery under general anesthesia

Procedure: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring

Interventions

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.

Children

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children in the pediatric surgical wardof: * Lille University hospital (Lille, France) * Armand Trousseau Hospital (Paris, France)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne LAFFARGUE, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 16, 2020
• Study Start: June 23, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

FR (1)