EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care

Study Overview
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Brief Summary
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Electroencephalographic recordings (EEG) present an opportunity to monitor changes in human brain electrical activity during changing states of consciousness during general anesthesia. The investigators aim to determine if EEG-guided anaesthesia using the Masimo Sedline Root monitor will result in different anaesthetic requirements, different anaesthetic depth, and emergence characteristics in children under 16 years of age. 200 children under 16 years undergoing routine general anaesthesia under sevoflurane will be randomized to either EEG monitoring or routine care. We will compare the anaesthetic requirements, the patient state index, number of episodes of burst suppression and the incidence and severity of emergence delrium between the two groups.

Detailed Description
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Electroencephalographic recordings (EEG) present an opportunity to monitor changes in human brain electrical activity during changing states of consciousness during general anesthesia. At present, monitoring of the brain under anaesthesia is not routinely employed. Since every patient is different and the way their brain response to anaesthetic drugs is different, it is important to adjust the patients' anaesthetic depth according to their brains' response, rather than only relying on routine cardiorespiratory parameters. This is important particularly for children, whose physiological responses and electroencephalographic recordings (EEG) differ from that of adults. 200 children under 16 years undergoing routine sevoflurane general anaesthesia will be randomized to either EEG-guided anaesthesia or routine care. The investigators will compare the anaesthetic requirements, the patient state index, number of episodes of burst suppression and the incidence and severity of emergence delrium between the two groups.

Official Title
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EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care

Conditions
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Depth of Anaesthesia, EEG, Anesthesia Emergence Delirium

Intervention / Treatment
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* Device: Sedline EEG sensor placement
* Device: Sedline EEG monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 1-16 years old scheduled to undergo general sevoflurane anaesthesia for surgeries or procedures anticipated to last at between 30 minutes to 4 hours. Exclusion Criteria: Patients with neurological diseases including seizure disorders Patients with developmental delay or genetic syndromes Patients with craniofacial deformities where it is not possible to place the EEG sensors Patients with severe eczema or skin allergy or atopy. Patients who are having craniofacial surgery where it is not possible to place the EEG sensors Patients whose foreheads are too small to accommodate the EEG sensors. Patients who require sedative premedications.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG-Guided Anaesthesia<br>Patients will have Sedline EEG sensor placed and anaesthesia guided by the EEG characteristics, patient state index (PSI) and suppression ratio (SR), in addition to routine clinical parameters. | Device: Sedline EEG sensor placement<br>* Patients will have Sedline EEG sensor placed before or immediately after induction.<br>Device: Sedline EEG monitoring<br>* Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters<br>|
| Active Comparator: Routine Care<br>Patients will have Sedline EEG sensor placed but the monitor is concealed so the clinician is blinded to the EEG response. Anaesthesia is guided by routine clinical parameters. | Device: Sedline EEG sensor placement<br>* Patients will have Sedline EEG sensor placed before or immediately after induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End tidal sevoflurane concentration at induction | Average sevoflurane concentration (MAC) required during induction | 6 hours: within the intraoperative period | 
| End tidal sevoflurane concentration for maintenance | Average sevoflurane concentration (MAC) required during maintenance | 6 hours: within the intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence delirium incidence | Incidence of emergence delirium as measured by the PAED scale | Within 3 hours: Postoperative in PACU | 
| Emergence delirium severity | Severity of emergence delirium as measured by the PAED scale | Within 3 hours: Postoperative in PACU | 
| Post-operative behaviour | Post-operative maladaptive behaviour | Within 2 weeks after surgery | 
| Burst Suppression Incidence | Incidence of burst suppression | 6 hours: within the intraoperative period | 
| Burst Suppression Duration | Duration of burst suppression | 6 hours: within the intraoperative period | 
| Burst suppression probability | Burst suppression probability during maintenance, summarized by the mean over the maintenance period | During maintenance of anaesthesia (up to 4 hours) | 
| PSI | Patient state index during maintenance of anaesthesia | 6 hours: within the intraoperative period |