EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
NCT ID: NCT04103138
Last Updated: 2022-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
200 participants
INTERVENTIONAL
2019-09-26
2021-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sedline EEG Guided Depth of Anesthesia
NCT05051982
The Alternative Position for the SedLine® Sensor
NCT03947060
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
NCT03128931
Study of Pharmacological and Clinical Correlates of Frontal Cortical Electroencephalographic (EEG) Signal During the Induction, Maintenance and Emergence Phases of Anesthesia in Children
NCT06020599
Improving Information Extraction From EEG on Cerebral Anesthetic Drug Effects
NCT02043938
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EEG-Guided Anaesthesia
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.
Sedline EEG sensor placement
Patients will have Sedline EEG sensor placed before or immediately after induction.
Sedline EEG monitoring
Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters
Routine Care
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.
Sedline EEG sensor placement
Patients will have Sedline EEG sensor placed before or immediately after induction.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sedline EEG sensor placement
Patients will have Sedline EEG sensor placed before or immediately after induction.
Sedline EEG monitoring
Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
1 Year
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
KK Women's and Children's Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
KK Women's and Children's Hospital
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIRB 2019/2235
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.