Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing carDiac surgERies (PATHFINDERII)

Beth Israel Lahey Health

Status: Completed

Conditions: Hemodynamic Instability; Neurocognitive Dysfunction; Pain; Postoperative Delirium

Treatments: Drug: Propofol; Drug: Dexmedetomidine; Drug: Rocuronium; Drug: Remifentanil; Drug: Ketamine; Device: EEG Monitoring; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05279898

2021-P-000889

Details and patient eligibility

About

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 analgesic approach to:

1. reduce the incidence of perioperative neurocognitive dysfunction in cardiac surgical patients
2. ensure hemodynamic stability and decrease use of vasopressors in the operating rooms
3. reduce pain and opioid consumption postoperatively

Full 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 on the use of sevoflurane for unconsciousness and intermittent doses of fentanyl and hydromorphone for antinociception.

The team will test the intraoperative EEG-guided MMGA management strategy in combination with a postoperative protocolized analgesic approach to reduce the postoperative increase of surgical and delirium markers, reduce intraoperative abnormalities in brain health monitoring, ensure hemodynamic stability and decreased use of vasopressors in the operating rooms and reduce pain and opioid consumption postoperatively. The team will also investigate whether EEG-guided MMGA strategy reduces the incidence of perioperative neurocognitive dysfunction in cardiac surgical patients. This approach will further individualize care and minimize the use of intraoperative vasopressor-inotropic dose, dose of anesthetic medications, and postoperative opioids given to each patient potentially preventing hemodynamic complications and post-operative cognitive dysfunction after surgery.

Enrollment: 70 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Multimodal General Anesthesia (MMGA Bundle) - EEG Guided

Experimental group

Description:

1. Routine anesthetic induction 2. 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) 3. Ketamine (0.1 to 0.2 mg.kg/hr) 4. Remifentanil (0.05-0.4 mcg/kg/min) 5. Dexmedetomidine (0.2-0.5 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion (15 to 200 mcg/kg/min) Postop 1. 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) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group) 5. Lidocaine patches

Treatment:

Drug: Ropivacaine

Device: EEG Monitoring

Drug: Remifentanil

Drug: Ketamine

Drug: Rocuronium

Drug: Dexmedetomidine

Drug: Propofol

Standard of Care/Control

No Intervention group

Description:

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 1. 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) 2. Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation 3. Propofol infusion may be added/used for sedation based on the treating physician's discretion 4. Lidocaine patches 5. Parasternal block (PIFB or Transversus Thoracic Plane Block) on Postoperative day 0 - currently incorporated into standard pain management after surgery based on physician discretion