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PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients — PANDORA  

Coronary Artery Disease Clinical Trial

Official title:
PANDORA: Scheduled Prophylactic 6-hourly Intravenous Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients

Clinical Trial Summary

Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04093219
Study type Interventional
Source Beth Israel Deaconess Medical Center
Contact Balachundhar Subramaniam, MD, MPH
Phone 617-754-2721
Email bsubrama@bidmc.harvard.edu
Status Recruiting
Phase Phase 3
Start date August 11, 2020
Completion date October 2024
View Details
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