- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07567729
Effectiveness of Electroencephalography Guided Anesthesia (EEG Anesthesia)
April 30, 2026 updated by: David R. Drover, Stanford University
A Pilot Study to Evaluate the Feasibility of EEG-guided Anesthesia Protocol to Reduce POD
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
225
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ariel Clinical Research Coordinator Associate
- Phone Number: 650-724-3021
- Email: arielkay@stanford.edu
Study Contact Backup
- Name: Maya Clinical Research Coordinator Associate
- Phone Number: 650-724-2620
- Email: mcaple@stanford.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Part A Inclusion Criteria:
- 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.
Currently practicing anesthetic provider, defined as either:
- Attending anesthesiologist, or
- Certified Registered Nurse Anesthetist (CRNA).
- Limited prior formal training in EEG interpretation for anesthetic depth, as self-reported by the participant (see Exclusion Criteria for details).
- 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.
- Willingness to adhere to the protocol-specified anesthetic management strategy during the real-case assessments.
Part B Inclusion Criteria:
- Provides written, signed informed consent prior to the surgical procedure.
- Is age 60 years or older.
- Is scheduled to undergo an elective, non-cardiac, non-neurologic surgical procedure expected to last at least two hours.
- Is planned to receive general anesthesia.
- Has an American Society of Anesthesiologists (ASA) physical status of I, II, or III.
- Has intact skin on the forehead suitable for the application of EEG electrodes.
Exclusion Criteria:
Part A Exclusion Criteria:
- Fellowship training in neuroanesthesia or neurocritical care.
- Participation in EEG-related research or formal EEG training within the past 12 months.
- Inability to access or utilize required technology (e.g., computer or tablet with internet access) necessary for completion of digital modules and online assessments.
- Any condition (physical, psychological, or cognitive) that, in the opinion of the site investigator, would preclude full participation in study activities or completion of the study protocol.
- Known allergy or sensitivity to materials used in EEG electrodes (e.g., adhesives or gels), if applicable.
- Non-practicing anesthetic providers (e.g., retired, not currently providing clinical care).
Part B Exclusion Criteria:
- Is unable to provide legally effective informed consent.
- Is scheduled for emergency, cardiac, or neurologic surgery.
- Has an American Society of Anesthesiologists (ASA) physical status of IV or greater.
- Has a pre-existing diagnosis of dementia, significant cognitive impairment, or other major neurologic disease (e.g., epilepsy, Parkinson's disease).
- Has a known allergy to the adhesives or gels used with EEG electrodes.
- Has a condition, such as a craniofacial deformity or skin condition on the forehead, that would prevent proper placement or functioning of the EEG monitor.
- Currently pregnant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Part A: Anesthesia Providers that Receive Training
Eligible anesthesia providers that include both anesthesiologists and CRNAs who will receive an EEG-guided anesthesia training program for anesthesia providers.
|
The 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.
|
|
No Intervention: Part A: Anesthesia Providers that Do Not Receive Training
Eligible anesthesia providers that include both anesthesiologists and CRNAs who will did not receive an EEG-guided anesthesia training program for anesthesia providers.
|
|
|
Other: Part B: All Participants Receive the EEG-Guided Intervention
Part B will be a prospective, single-arm pilot study.
As a result, randomization of patients into different groups will not occur, and all patients will receive the EEG-guided intervention.
Blinding of the intraoperative clinical team is also not feasible in this case, as providers must be aware of all monitoring tools in use.
Instead, this study will mitigate potential for bias by utilizing blinded outcome assessors.
Researchers will be kept separate from the intraoperative care team to remain unaware of specific details of the patient's anesthetic course.
|
All 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minimum Alveolar Concentration (MAC)
Time Frame: Intra-operative phase of care of participant.
|
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.
|
Intra-operative phase of care of participant.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
Time Frame: Postoperative Days 1 to 3.
|
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.
|
Postoperative Days 1 to 3.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
January 1, 2031
Study Registration Dates
First Submitted
April 24, 2026
First Submitted That Met QC Criteria
April 30, 2026
First Posted (Actual)
May 5, 2026
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 82323
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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