Effectiveness of Electroencephalography Guided Anesthesia
ConditionDelirium - Postoperative
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
This study will use brain wave information, known as electroencephalography (EEG), to help guide anesthesia delivery during surgery. It is believed that the use of EEG has the potential to reduce postoperative delirium - a common side effect of general anesthesia. Postoperative delirium is known to cause long lasting cognitive deficits and increase the chance of developing dementia in geriatric patients. This study aims to reduce these risks posed by modern day anesthesia practices through more efficient delivery of anesthesia utilizing brain wave activity information.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed and dated informed consent form prior to any study-specific procedures.
Willingness and ability to comply with all study procedures and availability for the duration of the study, including all scheduled assessments and follow-up visits.
Attending anesthesiologist, or
Certified Registered Nurse Anesthetist (CRNA).
Disqualifiers
Fluent in English, to ensure comprehension of study materials and assessments.
Able to access and utilize required technology (e.g., computer or tablet with internet access) for completion of digital modules and online assessments.
In good general health and capable of fulfilling clinical duties, as self-reported and confirmed by site investigator review.
Willingness to be randomized to any of the study arms and to participate in all assigned educational interventions and assessments.
Trial design
Design model
Parallel
Treatments tested in this trial
EEG-guided anesthesia training program for anesthesia providers
Other interventionThe EEG-guided anesthesia training session for the anesthesia providers will administer simulation-based assessments at baseline, immediately post-intervention, and at one, three, and six month follow-up time points to track provider competency in EEG interpretation and anesthetic titration.
EEG-Guided Intervention
DeviceAll surgical patients in Part B of the study will receive EEG-guided anesthesia. EEG data collected from patient participants will be provided as live data during their surgical procedures to the anesthesia provider. Anesthesia providers may use this data to assist their decision-making on anesthetic delivery.
Treatment groups
225 Participants
are divided into 3 treatment groupsGroup A: Part A: Anesthesia Providers that Receive TrainingActive comparator 1 intervention
Group B: Part A: Anesthesia Providers that Do Not Receive TrainingNo intervention 0 interventions
Group C: Part B: All Participants Receive the EEG-Guided InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
Minimum Alveolar Concentration (MAC)
The primary endpoint is the total intraoperative anesthetic exposure. This will be measured as the time-weighted average of the age-adjusted Minimum Alveolar Concentration (MAC) of volatile anesthetic administered during the maintenance phase of anesthesia. These data will be collected directly from the electronic anesthetic record for each enrolled patient case and will be reviewed and verified by the study team.
Time frame
Intra-operative phase of care of participant.Secondary outcomes
1
3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
To gather data for POD progression modeling, patients will be assessed for delirium daily for the first three postoperative days using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM). These assessments will be performed by trained research staff who are blinded to the patient's treatment group.
Time frame
Postoperative Days 1 to 3.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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