Trials / Completed
CompletedNCT04016740
The PATHFINDER Study: A Feasibility Trial
Perioperative Multimodal General Anesthesia Focusing on Specific CNS Targets in Patients Undergoing Cardiac Surgeries
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Beth Israel Deaconess Medical Center · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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.
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 after anesthesia and surgery, decrease in postoperative delirium, and decrease in long term postoperative cognitive dysfunction up to 6 months following cardiac surgery. Specific Aim 1: The feasibility of implementing multimodal general anesthesia strategy in the Operating Rooms (OR) Specific Aim 2: The feasibility of implementing EEG guided sedation until extubation in the Intensive Care Unit (ICU) Specific Aim 3: The enhancement of recovery after surgery (shorter ventilation time, ICU stay, hospital length of stay) Specific Aim 4: To estimate the effect size of decrease in postoperative day (POD) and postoperative cognitive dysfunction (POCD) to power future large randomized trials
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | Ketamine | 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 |
Timeline
- Start date
- 2019-08-20
- Primary completion
- 2020-02-19
- Completion
- 2020-07-07
- First posted
- 2019-07-11
- Last updated
- 2021-01-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04016740. Inclusion in this directory is not an endorsement.