NIPE Monitoring Values During Routine Pediatric Anesthesia

Completed

• Conditions: Anesthesia; Nociceptive Pain
• Interventions: Procedure: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring

• Registration Number: NCT04432480
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2020-06-23
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children	NIPE (Newborn Infant Parasympathetic Evaluation) monitoring	0-15 years old children undergoing surgery under general anesthesia

Primary Outcome Measures

Name	Time	Method
Variation of the instantaneous NIPE index after opioid administration	5 minutes after opioid administration

Secondary Outcome Measures

Name	Time	Method
Variation of the instantaneous NIPE index after skin incision	5 minutes after skin incision
the area under the ROC curve of NIPE value	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
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 insertion of airway control device	5 minutes after insertion of airway control device
Variation of the instantaneous NIPE index after anesthetic induction	5 minutes after anesthetic induction

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France