Clinical trial NCT04103138: EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
Official title: EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depth of Anaesthesia
EEG
Anesthesia Emergence Delirium
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2019-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: End tidal sevoflurane concentration at induction
timeFrame: 6 hours: within the intraoperative period
measure: End tidal sevoflurane concentration for maintenance
timeFrame: 6 hours: within the intraoperative period
Secondary outcomes:
measure: Emergence delirium incidence
timeFrame: Within 3 hours: Postoperative in PACU
measure: Emergence delirium severity
timeFrame: Within 3 hours: Postoperative in PACU
measure: Post-operative behaviour
timeFrame: Within 2 weeks after surgery
measure: Burst Suppression Incidence
timeFrame: 6 hours: within the intraoperative period
measure: Burst Suppression Duration
timeFrame: 6 hours: within the intraoperative period
measure: Burst suppression probability
timeFrame: During maintenance of anaesthesia (up to 4 hours)
measure: PSI
timeFrame: 6 hours: within the intraoperative period
Other outcomes:
measure: Mean peak alpha frequency
timeFrame: During maintenance of anaesthesia (up to 4 hours)
measure: Mean peak alpha power
timeFrame: During maintenance of anaesthesia (up to 4 hours)
measure: Mean peak slow oscillation frequency
timeFrame: During maintenance of anaesthesia (up to 4 hours)
measure: Mean peak Slow oscillation power
timeFrame: During maintenance of anaesthesia (up to 4 hours)
measure: Variation in peak alpha frequency
timeFrame: During maintenance of anaesthesia (up to 4 hours)
measure: Variation in peak alpha power
timeFrame: During maintenance of anaesthesia (up to 4 hours)
measure: Phase amplitude modulation depth
timeFrame: During maintenance of anaesthesia (up to 4 hours)
measure: Phase amplitude modulation phase
timeFrame: During maintenance of anaesthesia (up to 4 hours)
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References: