Effectiveness of Electroencephalography Guided Anesthesia

NCT07567729 — Not applicable, Not yet recruiting, 225 participants, Stanford University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Pilot Study to Evaluate the Feasibility of EEG-guided Anesthesia Protocol to Reduce POD

RegistryNCT07567729, acronym EEG Anesthesia
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment225 (Estimated)
SponsorStanford University (Other)
ConditionsDelirium - Postoperative
InterventionsEEG-guided anesthesia training program for anesthesia providers, EEG-Guided Intervention (Other, device)
Datesstart 2026-06-01 (estimated), primary completion 2028-06-01 (estimated), completion 2031-01-01 (estimated), first posted 2026-05-05, last updated 2026-05-05

Related Papers Related Patents Related Grants Related Experts
All trials for Delirium - Postoperative All trials of EEG-guided anesthesia training program for anesthesia providers All trials of EEG-Guided Intervention

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Part A: Anesthesia Providers that Receive TrainingActive comparatorOther: EEG-guided anesthesia training program for anesthesia providersEligible anesthesia providers that include both anesthesiologists and CRNAs who will receive an EEG-guided anesthesia training program for anesthesia providers.
Part A: Anesthesia Providers that Do Not Receive TrainingNo interventionEligible 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 InterventionOtherDevice: EEG-Guided InterventionPart 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.
  • 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.
  • 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.

+Outcome measures

Primary outcomes

  • Minimum Alveolar Concentration (MAC) [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.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.