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General Anesthesia

Perioperative Multimodal General Anesthesia for Cardiac Surgery (PATHFINDERII Trial)

N/A

Recruiting

Led By Balachundhar Subramaniam, MD,MPH,FASA

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing coronary artery bypass surgery (CABG), CABG+valve surgeries, or isolated valve surgeries with cardiopulmonary bypass

Age ≥ 60 years

Must not have

Emergent surgery

Liver dysfunction (liver enzymes > 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will be assessed for delirium at 1 month and 6 months following the date of surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new way of giving anesthesia during surgery that could lead to less pain and fewer side effects afterwards.

Who is the study for?

This trial is for people aged 60 or older who are having heart surgery with cardiopulmonary bypass but don't have severe heart failure, aren't in urgent need of surgery, can speak English, aren't on high doses of opioids for chronic pain, don't have a known sensitivity to the study drugs, no recent heavy alcohol or drug use, and not severely cognitively impaired.

What is being tested?

The PATHFINDER 2 trial is testing a special anesthesia strategy during and after heart surgery. It uses EEG monitoring to guide medication like Ketamine and Dexmedetomidine aiming to reduce brain function issues post-surgery, stabilize blood pressure without many extra drugs (vasopressors), and lessen pain plus opioid needs after surgery.

What are the potential side effects?

Possible side effects include allergic reactions to medications used; changes in blood pressure; dizziness; nausea; confusion or memory problems due to Ketamine; sleepiness from Dexmedetomidine; muscle weakness from Rocuronium; and liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for heart surgery involving bypass or valve replacement.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery urgently.

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My liver is not working properly, indicated by high enzyme levels or signs of jaundice.

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I do not speak English.

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I have been taking opioids equivalent to 30 mg of morphine or more daily for over a month in the past year for chronic pain.

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I have major difficulty seeing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will be assessed for delirium at 1 month and 6 months following the date of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will be assessed for delirium at 1 month and 6 months following the date of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be assessed for delirium at 1 month and 6 months following the date of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Increase in plasma IL-6 levels

Increase in plasma Neurofilament light levels

Secondary study objectives

Burst suppression

Cognitive Function

Concurrent EEG burst suppression and cerebral desaturation

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal General Anesthesia (MMGA Bundle) - EEG GuidedExperimental Treatment7 Interventions

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

Group II: Standard of Care/ControlActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remifentanil

2019

Completed Phase 4

~1610

Rocuronium

2014

Completed Phase 4

~1680