Status:
COMPLETED
Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing carDiac surgERies
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Postoperative Delirium
Hemodynamic Instability
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
In the PATHFINDER 2 trial, the study investigators will test the intraoperative EEG-guided multimodal general anesthesia (MMGA) management strategy in combination with a postoperative protocolized ana...
Detailed Description
The investigators propose to randomize (1:1) 70 patients undergoing cardiac surgery to the perioperative EEG-guided MMGA bundle (described in full below) or standard-of-care management based primarily...
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 :
February 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05279898
Start Date
February 28 2023
End Date
December 31 2024
Last Update
November 26 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115