Clinical trial NCT04016740: The PATHFINDER Study: A Feasibility Trial
Official title: Perioperative Multimodal General Anesthesia Focusing on Specific CNS Targets in Patients Undergoing Cardiac Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Coronary Artery Disease
Delirium
Keywords: Cardiopulmonary Bypass
Cardiac Surgery
analgesics
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 2 roll-in patients followed by 20 patients in the interventional model.
Primary purpose: OTHER

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60 years
2. 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:

1. Preoperative left ventricular ejection fraction (LVEF) \<30%
2. Emergent surgery
3. Non-English speaking
4. Cognitive impairment as defined by total MoCA score \< 10
5. Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
6. Significant visual impairment
7. 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)
8. Hypersensitivity to any of the study medications
9. 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
10. Liver dysfunction (liver enzymes \> 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.

Primary outcomes:
measure: Incidence of Delirium
timeFrame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Secondary outcomes:
measure: Time to extubation
timeFrame: Time of ICU admission until time of extubation in ICU, an average of 6 hours
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: On the day of discharge, an average of 6 days
measure: Pain scores
timeFrame: At 4-8 hourly intervals every day until discharge, an average of 6 days
measure: Total opioid and supplemental analgesic consumption
timeFrame: 48 hours, post-operative
measure: ICU
timeFrame: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
measure: ICU/hospital length of stay
timeFrame: Time of stay in the hospital until discharge to floor or rehab, an average of 5 days
measure: In-hospital complications
timeFrame: 7 days post-op on an average
measure: Follow up incidence of delirium
timeFrame: Patients will be assessed for delirium at 1 month and 6 months following the date of surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundhar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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