Recruiting

Observational Study

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06133842

Conditions

Perioperative/Postoperative Complications

Postoperative Cognitive Dysfunction

Postoperative Delirium

EEG With Periodic Abnormalities

Intraoperative Hypotension

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Intra-op EEG and CO data collection

Study Details

Brief summary:

The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question\[s\] it aims to answer are:

  • Is there a way to tailor the blood pressure to be maintained in such patients during surgery for optimal brain health using non-invasive monitors that check the brains electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood oxygen levels, the cerebral oximetry(CO) monitor?
  • How much does this optimal blood pressure level vary between patients?

Participants will be asked to:

  • Complete a questionnaire at the time they enroll into the study, as well as a daily questionnaire to help determine their level of thinking and brain health. This questionnaire will be administered by a member of the study team.
  • They will also have an EEG and CO monitoring sticker placed on their foreheads. This will be connected to a monitor that will collect this data just before, during, and after their surgery. The data collected through these monitors will help us with our study goals.

Conditions

Perioperative/Postoperative Complications

Postoperative Cognitive Dysfunction

Postoperative Delirium

EEG With Periodic Abnormalities

Intraoperative Hypotension

Study ID

NCT06133842

Start date

Apr 17, 2024

Status verified date

Oct, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age ≥ 60 years
  • Undergoing any non-cardiac surgeries including but not limited to vascular, hepatobiliary, or complex spine surgeries requiring general anesthesia with arterial catheterization for monitoring

Exclusion Criteria:

1. Non-English speaking (Justification: cognitive assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
2. Cognitive impairment as defined by total MoCA score < 10 (justification: baseline cognitive dysfunction will confound primary outcome measure)
3. Significant visual impairment (justification: will be difficult for patients to draw individual components in MOCA score)
4. Emergent surgery (justification: insufficient time to initiate intervention)
5. History of stroke within the last 3 months (justification: cognitive dysfunction secondary to stroke can confound outcome measures

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Enrolled Participants

Patients above the age of 60 undergoing major non-cardiac surgery requiring invasive MAP monitoring as standard of care. They will be monitored intra-op using non-invasive EEG and CO monitors, which will be correlated with MAP.

They will also undergo baseline and followup assessment for post-operative delirium using the standardised CAM and MoCA tools administered by study staff.

Interventions

Intra-op EEG and CO data collection

Intra-op EEG and CO data will be collected non-invasively. This will not guide or affect patient care of procedure in any way.

Primary outcome measure

  • CA state and lower limits of autoregulation (LLA): [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Samir M Kendale, MD

(617) 975-8500skendale@bidmc.harvard.edu

Zaid Hussain, MBBS

zhussai1@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Samir Kendale, MD

skendale@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • EEG
  • Cerebral Autoregulation
  • Intraoperative Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-10-28.