EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care (EEGPAC)

KK Women's and Children's Hospital

Status: Completed

Conditions: EEG; Anesthesia Emergence Delirium; Depth of Anaesthesia

Treatments: Device: Sedline EEG monitoring; Device: Sedline EEG sensor placement

Study type: Interventional

Funder types: Other

Identifiers

NCT04103138

CIRB 2019/2235

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

EEG-Guided Anaesthesia

Experimental group

Description:

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.

Treatment:

Device: Sedline EEG monitoring

Device: Sedline EEG sensor placement

Routine Care

Active Comparator group

Description:

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.

Treatment:

Device: Sedline EEG sensor placement