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PANDORA Study

UCI Specialty Area: Trauma & Critical Care
Principal Investigator: Jay Shen
Official Title: Scheduled Prophylactic 6-Hourly IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients: A Randomized Controlled Trial
A Study On:
Anesthesia

Study Description

This project will study the impact of scheduled administration of IV acetaminophen on the incidence, duration, and severity of postoperative delirium and other important hospital outcomes. Additionally, this trial will evaluate the effects of IV acetaminophen on longer-term postoperative cognitive dysfunction and functional status and develop a biorepository of perioperative samples as a future resource to probe the mechanisms of postoperative delirium.

The investigators propose three specific aims by conducting a randomized, triple-blind clinical trial that enrolls 900 patients 60 years of age or older undergoing cardiac surgery. Through this trial, the investigators will determine the effect of IV acetaminophen on;

  1. the incidence, duration, and severity of postoperative delirium,
  2. the use of opioids and other rescue analgesics in the first 48 postoperative hours, daily pain scores at rest and exertion, and length of stay in the Intensive Care Unit and overall hospital length of stay
  3. longer-term (one, six, 12 months) cognitive, physical, and self-care functional recovery after surgery.

Eligibility

  1. Greater than or equal to 60 years of age
  2. Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass
  1. Pre-operative left ventricular ejection fraction (LVEF) < than 30%
  2. Emergent procedures
  3. Isolated aortic surgery
  4. Liver dysfunction (liver enzymes > 3 times the baseline, all patients will have a baseline liver function test information), history and exam suggestive of jaundice
  5. Hypersensitivity to the study drugs
  6. Active (in the past year) history of alcohol abuse (greater than or equal to 5 drinks per day for men or greater than or equal to 4 drinks per day for women)
  7. Any history of alcohol withdrawal or delirium tremens
  8. Delirium at baseline
  9. Non-English speaking
  10. Prisoners
  11. Physician Refusal
  12. COVID-19 Positive, symptomatic
  13. Co-enrollment with non-approved interventional trial
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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