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NIPE Monitoring Values During Routine Pediatric Anesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04432480
Acronym
OMNIPED
Enrollment
90
Registered
2020-06-16
Start date
2020-06-23
Completion date
2021-12-31
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Nociceptive Pain

Keywords

General anesthesia, Nociceptive Pain, Monitoring, Pediatric anesthesia

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.

Interventions

PROCEDURENIPE (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.

Sponsors

Fondation Apicil
CollaboratorOTHER
University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Variation of the instantaneous NIPE index after opioid administration5 minutes after opioid administration

Secondary

MeasureTime frameDescription
the area under the ROC curve of NIPE valueBaseline 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 skin incision5 minutes after skin incision
Variation of the instantaneous NIPE index after insertion of airway control device5 minutes after insertion of airway control device
Variation of the instantaneous NIPE index after removal of airway control device5 minutes after removal of airway control device
Variation of the instantaneous NIPE index after anesthetic induction5 minutes after anesthetic induction

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026