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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

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 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

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
Ketamine
2011
Completed Phase 4
~1120
Dexmedetomidine
2015
Completed Phase 4
~2050
EEG Monitoring
2006
N/A
~70
Ropivacaine
2017
Completed Phase 4
~1960
Propofol
2017
Completed Phase 4
~1520

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
848 Previous Clinical Trials
12,930,034 Total Patients Enrolled
Balachundhar Subramaniam, MD,MPH,FASAPrincipal InvestigatorBeth Israel Deaconess Medical Center

Media Library

Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets (General Anesthesia) Clinical Trial Eligibility Overview. Trial Name: NCT05279898 — N/A
Neurocognitive Disorder Research Study Groups: Multimodal General Anesthesia (MMGA Bundle) - EEG Guided, Standard of Care/Control
Neurocognitive Disorder Clinical Trial 2023: Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets Highlights & Side Effects. Trial Name: NCT05279898 — N/A
Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets (General Anesthesia) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05279898 — N/A
~28 spots leftby Sep 2025
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