Status:
COMPLETED
The PATHFINDER Study: A Feasibility Trial
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Coronary Artery Disease
Delirium
Eligibility:
All Genders
60+ years
Phase:
EARLY_PHASE1
Brief Summary
The main purpose of this study is to determine whether a rational strategy of EEG guided multimodal general anesthesia using target specific sedative and analgesics could result in enhanced recovery a...
Detailed Description
The main purpose of this study is to determine whether a rational strategy of EEG guided multimodal general anesthesia using target specific sedative and analgesics could result in enhanced recovery a...
Eligibility Criteria
Inclusion
- Age ≥ 60 years
- Undergoing any of the following types of surgery with cardiopulmonary bypass limited to coronary artery bypass surgery (CABG), CABG+valve surgeries and isolated valve surgeries.
Exclusion
- Preoperative left ventricular ejection fraction (LVEF) \<30%
- Emergent surgery
- Non-English speaking
- Cognitive impairment as defined by total MoCA score \< 10
- Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
- Significant visual impairment
- Chronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
- Hypersensitivity to any of the study medications
- Known history of alcohol (\> 2 drinks per day) or drug abuse Active (in the past year) history of alcohol abuse (≥5 drinks/day for men or ≥4 drinks/day for women) as determined by reviewing medical record and history given by the patient
- Liver dysfunction (liver enzymes \> 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04016740
Start Date
August 20 2019
End Date
July 7 2020
Last Update
January 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215