Monitoring brain health during non-cardiac surgery in older patients
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State - CERBERUS Trial
This study looks at the best blood pressure levels to keep during non-heart surgeries for older patients to help protect their brain health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06133842 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the optimal mean arterial pressure (MAP) to maintain during non-cardiac surgeries for patients aged 60 and above, focusing on brain health. It utilizes non-invasive monitoring techniques, including EEG and cerebral oximetry, to assess brain activity and blood oxygen levels. Participants will complete questionnaires to evaluate their cognitive function before and after surgery, while data will be collected in real-time during the procedure to understand individual variations in optimal blood pressure levels.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 and older scheduled for non-cardiac surgeries requiring general anesthesia.
Not a fit: Patients with significant cognitive impairment, non-English speakers, or those undergoing emergent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative cognitive outcomes and reduced incidence of delirium in older patients undergoing major surgeries.
How similar studies have performed: While the approach of using EEG and cerebral oximetry for monitoring during surgery is established, the specific focus on tailoring blood pressure for brain health in this population is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Samir M Kendale, MD
- Email: skendale@bidmc.harvard.edu
- Phone: (617) 975-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.