Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting. Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia. Their utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.

Detailed Description
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All patients monitored applying standard device for blood pressure, electrocardiogram and pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators will not assign any specific interventions to the subjects of the study.

Official Title
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Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.

Conditions
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Anesthesia, Child

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: physical status classification (ASA) I - II general balanced anesthesia mechanically ventilated with laryngeal mask Exclusion Criteria: severe developmental delay neurological disorders or receiving treatment with antiepileptic or stimulant patients with preexisting lung or cardiac disease airway abnormalities marked skin sensitivity and conditions where the placement of the BIS and Entropy sensor or process of assessment would interfere with the surgery procedure. patients receiving local anaesthesia, regional block combined with general anaesthesia sedation administered by non anesthesiologists for invasive and noninvasive diagnostic or therapeutic procedures

Ages Eligible for Study
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Minimum Age: 1 Month
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Children age between 1 month to 12 months | |
| Group 2<br>Children age between 13 months and 36 months | |
| Group 3<br>Children age between 37 months to 144 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BISPECTRAL Index | The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions. | BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours | 
| Entropy | The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions. | Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BISPECTRAL Index Awaking | In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer | reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia | 
| Entropy Awaking | In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer | reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depth anesthesia monitors, Children anesthesia, Bispectral monitor, Entropy monitor