Delirium - PostoperativeEEG AnesthesiaNCT07567729
Effectiveness of Electroencephalography Guided Anesthesia
A study testing EEG-guided anesthesia training program for anesthesia providers and EEG-Guided Intervention in people with Delirium - Postoperative, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium - Postoperative
- What is being tested?
- EEG-guided anesthesia training program for anesthesia providers and EEG-Guided Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Delirium - Postoperative
- Being tested
- EEG-guided anesthesia training program for anesthesia providers, EEG-Guided Intervention
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-guided anesthesia training program for anesthesia providersOther
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 InterventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EEG-Guided Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-operative phase of care of participant.
Secondary outcomes (1)
3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
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.
Measured: Postoperative Days 1 to 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David R. Drover, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567729
- Sponsor's protocol ID
- 82323
- Acronym
- EEG Anesthesia
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Feasibility of EEG-guided Anesthesia Protocol to Reduce POD
- ClinicalTrials.gov ID
- NCT07567729
- Acronym / sponsor ID
- EEG Anesthesia / 82323
- Conditions
- Delirium - Postoperative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part A: Anesthesia Providers that Receive Training | Active comparator | Other: 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 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG-guided anesthesia training program for anesthesia providersThe 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. | Other | Part A: Anesthesia Providers that Receive Training |
| EEG-Guided InterventionAll 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. | Device | Part B: All Participants Receive the EEG-Guided Intervention |
Primary outcome
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.
1 secondary outcome
3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
Time frame: Postoperative Days 1 to 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-guided anesthesia training program for anesthesia providers and EEG-Guided Intervention in people with Delirium - Postoperative, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Clinical Research Coordinator Associate (650-724-2620, mcaple@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Alveolar Concentration (MAC) (time frame: Intra-operative phase of care of participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.