A Pilot Study to Evaluate the Feasibility of EEG-guided Anesthesia Protocol to Reduce POD
| Registry | NCT07567729, acronym EEG Anesthesia |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 225 (Estimated) |
| Sponsor | Stanford University (Other) |
| Conditions | Delirium - Postoperative |
| Interventions | EEG-guided anesthesia training program for anesthesia providers, EEG-Guided Intervention (Other, device) |
| Dates | start 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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Part A: Anesthesia Providers that Receive Training | Active comparator | Other: EEG-guided anesthesia training program for anesthesia providers | Eligible 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 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 | Device: 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. |
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.