Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing carDiac surgERies (PATHFINDERII)
Postoperative Delirium, Hemodynamic Instability, Pain
About this trial
This is an interventional prevention trial for Postoperative Delirium
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Beth Israel Deaconess Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Multimodal General Anesthesia (MMGA Bundle) - EEG Guided
Standard of Care/Control
Routine anesthetic induction Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.2% ropivacaine on both sides of the sternum after anesthetic induction but before surgical incision (total of 40mL) Ketamine (0.1 to 0.2 mg.kg/hr) Remifentanil (0.05-0.4 mcg/kg/min) Dexmedetomidine (0.2-0.5 mcg/kg/hr) Rocuronium intermittent bolus (TOF) Propofol infusion (15 to 200 mcg/kg/min) Postop Standard pain management protocol IV Acetaminophen IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia Other oral pain medications as per standard of care (Oxycodone, etc) Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation Propofol infusion may be added/used for sedation based on the treating physician's discretion PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) Lidocaine patches
EEG monitoring will be blinded, and not guide anesthesiologists. Patients will receive standard/routine anesthesia practice intraoperatively. Postoperative Propofol infusion (15 to 200 mcg/kg/min) ± Sevoflurane Standard pain management protocol IV Acetaminophen (1 gram) x 4 doses at 6 hour intervals starting from 1 hr after ICU arrival IV Hydromorphone/fentanyl boluses as needed per current practice for rescue analgesia Other oral pain medications as per standard of care (Oxycodone, etc) Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation Propofol infusion may be added/used for sedation based on the treating physician's discretion Lidocaine patches Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion