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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
70
Perioperative monitoring, MMGA guided by EEG for intervention group
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)
Intraoperative infusion
Intraoperative infusion
Intraoperative infusion
Intraoperative intermittent bolus
Intraoperative infusion
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Increase in Plasma IL-6 Levels
Plasma interleukin-6 (IL-6) levels will be measured at baseline, postoperative day 1, and postoperative day 2. The change in IL-6 concentration from baseline to each postoperative time point will be calculated and compared between the study groups.
Time frame: Baseline, postoperative day 1, and postoperative day 2
Increase in Plasma Neurofilament Light Levels
Plasma neurofilament light (NfL) levels will be measured at baseline, postoperative day 1, and postoperative day 2. The change in NfL concentration from baseline to each postoperative time point will be calculated and compared between the study groups.
Time frame: Baseline, postoperative day 1, and postoperative day 2
Opioid Consumption
Total opioid consumption during the first 48 postoperative hours will be calculated by summing all opioid doses administered in any route and converting to intravenous morphine milligram equivalents (MME) for standardization. The cumulative 48-hour opioid dose will be compared between groups.
Time frame: From end of surgery to 48 hours postoperatively
Pain Scores
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), a validated 11-point scale that measures patient-reported pain intensity from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Scores will be obtained by nursing staff every 4-8 hours from electronic medical records, and the average 48-hour postoperative pain score will be compared between groups.
Time frame: From end of surgery to 48 hours postoperatively
Burst Suppression
Duration of burst suppression was extracted and quantified from the intraoperative EEG record and compared between the MMGA and control groups.
Time frame: intraoperative period, from anesthetic induction until the end of surgery
Postoperative Delirium
Incidence of Postoperative Delirium (POD) will be compared between both groups: POD will be diagnosed by our trained research members based on the Confusion Assessment Method (CAM) algorithm postoperatively until discharge.
Time frame: From postoperative day 1 until hospital discharge, an average of 4 days
Cognitive Function
Postoperative cognitive function will be assessed at 1 and 6 months after surgery using the telephone version of the Montreal Cognitive Assessment (t-MoCA). The t-MoCA has a total score range of 0 to 22, where higher scores indicate better cognitive function.
Time frame: Patients will be assessed for cognitive function at 1 month and 6 months following the date of surgery
Hemodynamic Stability - Total Vasopressor Dose
Metrics of total vasopressor dose in norepinephrine equivalents (mcg/kg/min) will be collected from the intra-operative record and medical records to be quantified and compared.
Time frame: Intraoperative period, from induction of anesthesia until transfer from the operating room
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