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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
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
PATHFINDERII Trial 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.Check my eligibility
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.See study design
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.
PATHFINDERII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for heart surgery involving bypass or valve replacement.
Select...
I am 60 years old or older.
PATHFINDERII Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Increase in plasma IL-6 levels
Increase in plasma Neurofilament light levels
Secondary outcome measures
Burst suppression
Cognitive Function
Concurrent EEG burst suppression and cerebral desaturation
+7 morePATHFINDERII Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal General Anesthesia (MMGA Bundle) - EEG GuidedExperimental Treatment7 Interventions
Routine anesthetic induction
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)
Ketamine (0.1 to 0.2 mg.kg/hr)
Remifentanil (0.05-0.4 mcg/kg/min)
Dexmedetomidine (0.2-0.5 mcg/kg/hr)
Rocuronium intermittent bolus (TOF)
Propofol infusion (15 to 200 mcg/kg/min)
Postop
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)
Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
Propofol infusion may be added/used for sedation based on the treating physician's discretion
PIFB on postoperative day 1 (provided they are extubated/getting ready to be extubated)(for intervention group)
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
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)
Dexmedetomidine infusion (0.4-1.4 mcg/kg/hr) - EEG Guided; Infusion continued till extubation
Propofol infusion may be added/used for sedation based on the treating physician's discretion
Lidocaine patches
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
Rocuronium
2014
Completed Phase 4
~1680
Remifentanil
2019
Completed Phase 4
~1610
Ketamine
2011
Completed Phase 4
~1090
Dexmedetomidine
2015
Completed Phase 4
~1980
EEG Monitoring
2006
N/A
~70
Ropivacaine
2017
Completed Phase 4
~1960
Propofol
2017
Completed Phase 4
~1530
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,202 Total Patients Enrolled
Balachundhar Subramaniam, MD,MPH,FASAPrincipal InvestigatorBeth Israel Deaconess Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery urgently.I am scheduled for heart surgery involving bypass or valve replacement.My liver is not working properly, indicated by high enzyme levels or signs of jaundice.You have consumed a lot of alcohol almost every day in the past year.You have a history of regularly drinking more than 2 alcoholic drinks per day or using drugs.I do not speak English.I am 60 years old or older.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.Your heart's pumping ability is very low before surgery.You have trouble with your memory and thinking, as indicated by a low MoCA score.I have major difficulty seeing.
Research Study Groups:
This trial has the following groups:- Group 1: Multimodal General Anesthesia (MMGA Bundle) - EEG Guided
- Group 2: Standard of Care/Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary purpose of this medical experiment?
"This 48-hour trial will be primarily assessing opioid consumption as the primary outcome. Additionally, secondary markers such as plasma cortisol levels, mean arterial blood pressure curve and systolic blood pressure will also be studied to evaluate delirium and hemodynamic stability respectively. Blood samples for these measurements will be collected at three distinct time points throughout the perioperative period."
Answered by AI
Are eligible individuals being accepted for this research right now?
"Unfortunately, clinicaltrials.gov indicates that recruitment for this particular medical study has closed as of June 13th 2022 -- the most recent update on record. However, there are currently 1057 other research trials seeking eligible candidates right now."
Answered by AI
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