NCT04103138

EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depth of Anaesthesia
• EEG
• Anesthesia Emergence Delirium

Interventions

Type	Name	Description
DEVICE	Sedline EEG sensor placement	Patients will have Sedline EEG sensor placed before or immediately after induction.
DEVICE	Sedline EEG monitoring	Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters

Timeline

• Start date: 2019-09-26
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-09-25
• Last updated: 2022-02-24

Locations

1 site across 1 country: Singapore