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CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State - CERBERUS Trial
Who can join
Ages 60 and older · All sexes · Healthy volunteers welcome
Full 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
About the study
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.
What is being tested
- Intra-op EEG and CO data collection (diagnostic test)
Sponsor: Beth Israel Deaconess Medical Center · Participants: 100 · Started: Apr 17, 2024
Contact the study team
- Samir M Kendale, MD · Phone: (617) 975-8500
Official record on ClinicalTrials.gov — NCT06133842
Locations in the U.S.
| Massachusetts | Beth Israel Deaconess Medical Center, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.