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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how to best manage blood pressure in patients over 60 years old during major non-cardiac surgeries, like vascular or spine surgeries, to protect brain health and reduce the risk of problems after surgery, such as confusion or cognitive issues. The researchers want to find out if they can personalize the blood pressure levels for each patient using special monitors that check brain activity and oxygen levels.

To participate, you need to be at least 60 years old and scheduled for a non-cardiac surgery that requires general anesthesia. If you join the study, you will fill out some questionnaires about your thinking and brain health, and you will wear small monitoring devices on your forehead before, during, and after surgery. These devices will help the researchers gather important information about your brain's condition during the surgery. It’s important to note that the study is looking for participants who do not have significant cognitive or visual impairments and are not having emergency surgery.

Gender

ALL

Eligibility 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:
• • 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