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CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State

Beth Israel Deaconess Medical Center · NCT06133842

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 60+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
100
US sites recruiting
1
Study start
April 17, 2024
Record last updated
September 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Intra-op EEG and CO data collection

Conditions: Perioperative/Postoperative Complications; Postoperative Cognitive Dysfunction; Postoperative Delirium; EEG With Periodic Abnormalities; Intraoperative Hypotension; Cerebral Hypoperfusion

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

  • 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.)
  • Cognitive impairment as defined by total MoCA score \< 10 (justification: baseline cognitive dysfunction will confound primary outcome measure)
  • Significant visual impairment (justification: will be difficult for patients to draw individual components in MOCA score)
  • Emergent surgery (justification: insufficient time to initiate intervention)
  • History of stroke within the last 3 months (justification: cognitive dysfunction secondary to stroke can confound outcome measures

Recruiting US locations

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Samir Kendale, MD · skendale@bidmc.harvard.edu

Study contacts (from the official record)

  • Samir M Kendale, MD · (617) 975-8500 · skendale@bidmc.harvard.edu
  • Zaid Hussain, MBBS · zhussai1@bidmc.harvard.edu
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CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to… (NCT06133842) | Bored Studies