NoL Index Response to Stimulation in Anesthetized Children

Study Overview
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Brief Summary
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The Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. The objective of this study was to investigate if the NoL index also indicates the level of nociception in anesthetized children. In children anesthetized according to standard practice, before surgical incision, three 5-seconds stimulations will be performed with different intensities (10, 30 and 60 milliamps). The order of the stimulations intensities will be randomized. The hypothesis of study is that the intensity of stimulation will influence the magnitude of NoL-index increase in response to the stimulation.

Official Title
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Nociception Level Index (NoL) Variation After Standardized Stimulation Under General Anesthesia in Children

Conditions
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Anesthesia

Intervention / Treatment
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* Device: NoL monitor
* Procedure: Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 5-12 years Elective surgery under general anesthesia Written informed consent Exclusion Criteria: Cardiac surgery Opioid intake < 24 hours before surgery Cardiac arrhythmia Pace maker Pheochromocytoma Anti-arrhythmic medication Anticholinergic medication Raynaud syndrome Digital anomaly (malformative, traumatic)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: In order to avoid the bias related to the order of the stimuli, the order of application of the stimuli will be randomized according to a Latin square of order 3.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children anesthetized<br>Inhalatory general anesthesia with sevoflurane 0.9 Minimal Alveolar Concentration and alfentanil 10 µg/kg | Device: NoL monitor<br>* NoL monitor : non invasive, adhesive digital device<br>Procedure: Stimulation<br>* Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation] | NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation] | 5 minutes after stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure (SBP) variation | SBP variation = [(Maximal SBP value in the 5 minutes following the stimulation) - (SBP before stimulation)] / [SBP before stimulation] | 5 minutes after stimulation | 
| Analgesia Nociception Index (ANI) variation | ANI variation = [(ANI before stimulation - (Minimal ANI value in the 5 minutes following the stimulation)] / [ANI before stimulation] | 5 minutes after stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monitoring, General anesthesia, Nociception, Nociception level, NoL