Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol

Study Overview
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Brief Summary
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Anesthesia is essential to control pain and produce unconsciousness during surgery and other procedures during childhood. The anesthetic deepness is measured indirectly through changes in blood pressure and heart rate or can be inferred according to estimated or measured concentrations of anesthetics. In adults, anesthetic dosing, using patterns based on electroencephalogram (EEG) analysis, has shown clinical advantages compared to traditional monitoring. These advantages include lower consumption of hypnotics, less post-operative cognitive deterioration and decreased intraoperative awakening. The maturation of the brain and Central Nervous System (CNS) that occurs in childhood affects the response of anesthetics. Additionally, the EEG changes with age and its dominant frequency is lower in children. This explains why brain monitoring methods developed in adults do not work well in children. However, these patterns cannot be extrapolated to the pediatric population. Therefore, it is necessary to develop indexes based on EEG with pediatric data to improve the dosage of hypnotics in this population. The appearance of alpha wave in frontal EEG has been successfully used as a marker of unconsciousness during general anesthesia with GABAergic hypnotics in adults (sevoflurane, propofol). However, in children, the alpha wave appears since 4 months of age in anesthetics with sevoflurane, so studying the characterization of this wave during the loss and recovery of secondary consciousness anesthetic agents such as propofol has not been studied yet.

Detailed Description
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Research question: Is it possible to use the alpha wave as an indicator of loss and recovery of consciousness in anesthesia with propofol in children? Hypothesis: The appearance and disappearance of frontal alpha wave is a good indicator of loss and recovery of consciousness in anesthesia with propofol in children.

Official Title
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Elaboration of a Predictive Model in EEG for Induction and Emergence in Pediatric Patients Under General Anesthesia With Propofol

Conditions
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Anesthesia, Electroencephalography, Children, Only

Intervention / Treatment
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* Device: Electroencephalography
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I - II Indications of phimosis surgery, cryptorchid and/or inguinal hernia surgery Exclusion Criteria: Anatomical limitations for installing the EEG cap. Congenital or genetic malformations that influence his/her brain development. Neurological or cardiovascular disease Use of drugs with effect in the CNS in the last 24 hrs. Preterm newborn less than 32 weeks.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Electroencephalography<br>Electroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol. | Device: Electroencephalography<br>* Measure the appearance and disappearance of frontal alpha wave with EE, when them loss and recovery of consciousness under general anesthesia with propofol.<br>Drug: Propofol<br>* Recorder the loss and recovery of consciousness in children under general anesthesia with TCI of propofol intravenous. Induction will be started with 20 mg/kg/hr of propofol up to UMSS level 4. Then will be titrated leading anesthesiologist criteria.<br>* Other names: General anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss and Recovery of consciousness | Recorded by the EEG signal - 40 channels waves: Beta, Alpha,Theta | Continuously from start of propofol infusion to unarousable up to ending of infusion arouses without stimuli. In average 2 hrs. | 
| Recovery of consciousness | Watching the awakening and/or gross movement. Recorded by Go Pro cam the moment of Recovery of consciousness. | From to ending of propofol infusion to arouses without stimuli. Continuously for 10 min. | 
| Loss of consciousness | Level 4 of University of Michigan Sedation Scale for children [0 0=awake/alert; 1=sleepy/responds appropriately; 2=somnolent/arouses to light stimuli ; 3=deep sleep/arouses to deeper physical stimuli; 4=unarousable to stimuli]. Recorded by Go Pro cam the moment of loss consciousness. | From start of propofol infusion to unarousable to stimuli. Continuously for 10 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Pressure | By non invasive Arterial Pressure: Systolic Arterial Pressure in mmHg, diastolic Arterial Pressure in mmHg and Medium Arterial Pressure in mmHg | Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs. | 
| Heart Rate | By EKG D-II bit per minute | Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs. | 
| Saturation Oxigen | Pulse Oximetry by reusable sensor in % of saturation. | Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Children, Electroencephalography, Propofol