Effectiveness of Electroencephalography Guided Anesthesia

NCT07567729 | Not Yet Recruiting FDA Device

• 1 other identifier: 82323
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Delirium - Postoperative

Outcome Measures

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.

  Intra-operative phase of care of participant.

Secondary Outcomes (1)

• 3-Minute Diagnostic Confusion Assessment Method (3D-CAM)

  Postoperative Days 1 to 3.

Study Arms (3)

Part A: Anesthesia Providers that Receive Training

ACTIVE COMPARATOR

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

Part A: Anesthesia Providers that Do Not Receive Training

NO INTERVENTION

Eligible anesthesia providers that include both anesthesiologists and CRNAs who will did not receive an EEG-guided anesthesia training program for anesthesia providers.

Part B: All Participants Receive the EEG-Guided Intervention

OTHER

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

Interventions

EEG-guided anesthesia training program for anesthesia providers OTHER

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.

Part A: Anesthesia Providers that Receive Training

EEG-Guided Intervention DEVICE

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.

Part B: All Participants Receive the EEG-Guided Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Maya Clinical Research Coordinator Associate

CONTACT

650-724-2620; mcaple@stanford.edu

Ariel Clinical Research Coordinator Associate

CONTACT

650-724-3021; arielkay@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: In Part A, researchers will be identifying eligible anesthesia providers that include both anesthesiologists and CRNAs via institutional rosters at Stanford Medical Center. Once enrollment is complete, an independent statistician will begin the randomization of participants into the intervention (training) or control (no training) groups using "computer-generated sequence stratified by participant years (\<10 years, 10-30 years, \>30 years) to ensure balanced allocation. 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.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04