The PATHFINDER Study: A Feasibility Trial
NCT04016740 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2021-01-28
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.
Conditions
- Coronary Artery Disease
- Delirium
Interventions
- DRUG
-
Ropivacaine
Intraoperative bilateral PIFB block with 20 mL of 0.25% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision
- DRUG
-
Intraoperative infusion
- DRUG
-
Remifentanil
Intraoperative infusion
- DRUG
-
Dexmedetomidine
Intraoperative infusion
- DRUG
-
Rocuronium
Intraoperative intermittent bolus
- DRUG
-
Propofol
Intraoperative infusion
- DRUG
-
Sevoflurane
Intraoperative inhaled as needed
- DRUG
-
Dexmedetomidine
Post-operative infusion
- DRUG
-
Propofol
Post-operative infusion
- DEVICE
-
EEG monitoring
Perioperative monitoring
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Balachundhar Subramaniam, MD, MPH · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-20
- Primary Completion
- 2020-02-19
- Completion
- 2020-07-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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