NIPE Monitoring Values During Routine Pediatric Anesthesia

Study Overview
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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.

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

Conditions
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Anesthesia, Nociceptive Pain

Intervention / Treatment
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* Procedure: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br>0-15 years old children undergoing surgery under general anesthesia | Procedure: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring<br>* Non invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the instantaneous NIPE index after opioid administration |  | 5 minutes after opioid administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the area under the ROC curve of NIPE value | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General anesthesia, Nociceptive Pain, Monitoring, Pediatric anesthesia