CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State
Recruiting now
Conditions studied: Perioperative/Postoperative Complications, Postoperative Cognitive Dysfunction, Postoperative Delirium, EEG With Periodic Abnormalities, Intraoperative Hypotension, Cerebral Hypoperfusion
In brief
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.
Key facts
- Study ID
- NCT06133842
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 100
- Starts
- 2024-04-17
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-10-28
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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