EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care

Not Applicable

Completed

• Conditions: Depth of Anaesthesia; Anesthesia Emergence Delirium; EEG
• Interventions: Device: Sedline EEG sensor placement; Device: Sedline EEG monitoring

• Registration Number: NCT04103138
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-08-25
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Study Start: 2019-09-26
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EEG-Guided Anaesthesia	Sedline EEG sensor placement	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.
EEG-Guided Anaesthesia	Sedline EEG monitoring	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.
Routine Care	Sedline EEG sensor placement	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.

Primary Outcome Measures

Name	Time	Method
End tidal sevoflurane concentration at induction	6 hours: within the intraoperative period	Average sevoflurane concentration (MAC) required during induction
End tidal sevoflurane concentration for maintenance	6 hours: within the intraoperative period	Average sevoflurane concentration (MAC) required during maintenance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore