The PATHFINDER Study: A Feasibility Trial

• Status: Completed
• Trial end date: 2020-07-07
• Target enrollment: 0
• Participant gender: All

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 after anesthesia and surgery, decrease in postoperative delirium, and decrease in long term postoperative cognitive dysfunction up to 6 months following cardiac surgery.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Dexmedetomidine; Ketamine; Propofol; Remifentanil; Rocuronium; Ropivacaine; Sevoflurane

Criteria

Inclusion Criteria:

1. Age ≥ 60 years

2. 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 Criteria:

1. Preoperative left ventricular ejection fraction (LVEF) <30%

2. Emergent surgery

3. Non-English speaking

4. Cognitive impairment as defined by total MoCA score < 10

5. Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI

6. Significant visual impairment

7. 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)

8. Hypersensitivity to any of the study medications

9. 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

10. Liver dysfunction (liver enzymes > 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.