EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- End tidal sevoflurane concentration at induction
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The subject and the outcome assessor analysing the EEG subsequently will be blinded to group allocation.
Eligibility Criteria
- Ages
- 1 Year to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
End tidal sevoflurane concentration at induction
Time Frame: 6 hours: within the intraoperative period
Average sevoflurane concentration (MAC) required during induction
End tidal sevoflurane concentration for maintenance
Time Frame: 6 hours: within the intraoperative period
Average sevoflurane concentration (MAC) required during maintenance
Secondary Outcomes
- Burst Suppression Incidence(6 hours: within the intraoperative period)
- Emergence delirium incidence(Within 3 hours: Postoperative in PACU)
- Emergence delirium severity(Within 3 hours: Postoperative in PACU)
- Post-operative behaviour(Within 2 weeks after surgery)
- Burst Suppression Duration(6 hours: within the intraoperative period)
- Burst suppression probability(During maintenance of anaesthesia (up to 4 hours))
- PSI(6 hours: within the intraoperative period)