NCT05279898

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

Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing carDiac surgERies - the PATHFINDER II Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Postoperative Delirium
• Hemodynamic Instability
• Pain
• Neurocognitive Dysfunction

Interventions

Type	Name	Description
DEVICE	EEG Monitoring	Perioperative monitoring, MMGA guided by EEG for intervention group
DRUG	Ropivacaine	Intraoperative bilateral PIFB block with 20 mL of 0.2% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision (total of 40mL) PIFB on postoperative day 1 (provided they are extubated or getting ready to be extubated) to help with mobilization (for intervention group)
DRUG	Ketamine	Intraoperative infusion
DRUG	Remifentanil	Intraoperative infusion
DRUG	Dexmedetomidine	Intraoperative infusion
DRUG	Rocuronium	Intraoperative intermittent bolus
DRUG	Propofol	Intraoperative infusion

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2022-03-15
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study