|

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

RECRUITINGSponsored by Beth Israel Deaconess Medical Center
Actively Recruiting
SponsorBeth Israel Deaconess Medical Center
Started2024-04-17
Est. completion2026-06
Eligibility
Age60 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 60 Years+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

Conditions7

Cerebral HypoperfusionEEG With Periodic AbnormalitiesHeart DiseaseIntraoperative HypotensionPerioperative/Postoperative ComplicationsPostoperative Cognitive DysfunctionPostoperative Delirium

Locations1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.