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COMPLETEDEARLY_PHASE1

The PATHFINDER Study: A Feasibility Trial

Perioperative Multimodal General Anesthesia Focusing on Specific CNS Targets in Patients Undergoing Cardiac Surgeries

NCT04016740•Beth Israel Deaconess Medical Center

Summary

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

Age

60 - No limit years

Sex

ALL

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.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

August 20, 2019

Primary Completion Date

February 19, 2020

Completion Date

July 7, 2020

Last Updated

January 28, 2021

Enrollment

ACTUAL participants

Conditions

Coronary Artery DiseaseDelirium

Interventions

Ropivacaine

DRUG

Ketamine

DRUG

Remifentanil

DRUG

Dexmedetomidine

DRUG

Rocuronium

DRUG

Propofol

DRUG

Sevoflurane

DRUG

Dexmedetomidine

DRUG

Propofol

DRUG

EEG monitoring

DEVICE

Virtual Reality for ICU Delirium Prevention

NCT07357389

ICU Delirium

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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The PATHFINDER Study: A Feasibility Trial

Inclusion Criteria

Exclusion Criteria

Virtual Reality for ICU Delirium Prevention

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium

"Erectile Function After PCI in MI and Non-MI Patients"

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision