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

Recruitingn/aAges 60 Years - anyAllBeth Israel Deaconess Medical Center
NCT06133842 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 w

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📋 Eligibility rules (as published)
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
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What it tests

  • Intra-op EEG and CO data collection
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Where

1 site
Beth Israel Deaconess Medical Center
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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