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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Device: EEG-Guided Intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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