The PATHFINDER Study: A Feasibility Trial

Beth Israel Lahey Health

Status and phase: Completed; Early Phase 1

Conditions: Coronary Artery Disease; Delirium

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04016740

2019P000407

Details and patient eligibility

About

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.

Full 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

Enrollment: 22 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Multimodal General Anesthesia

Experimental group

Description:

Intraoperative The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG. 1. Routine anesthetic induction 2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision 3. Ketamine (0.06 to 0.12 mg.kg/hr) 4. Remifentanil (0.05-0.2 mcg/kg/min) 5. Dexmedetomidine (0.2-1.0 mcg/kg/hr) 6. Rocuronium intermittent bolus (TOF) 7. Propofol infusion ± Sevoflurane titrated based on EEG monitoring Postoperative 1. Standard pain management protocol 2. Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided) 3. Infusion continued till extubation 4. Propofol infusion may be added/used for sedation based on the treating physician's discretion

Treatment:

Drug: Sevoflurane

Drug: Propofol

Drug: Ropivacaine

Drug: Propofol

Drug: Dexmedetomidine

Drug: Ketamine

Drug: Rocuronium

Device: EEG monitoring

Drug: Dexmedetomidine

Drug: Remifentanil

Standard Practice with EEG monitoring

Other group

Description:

The initial 2 patients will receive standard anesthesia practice and perioperative EEG monitoring will be recorded to learn the patterns associated with our standard practice.

Treatment:

Device: EEG monitoring