NCT04093219

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Delirium in Old Age
• Delirium
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	IV acetaminophen	use of IV tylenol for pain
OTHER	Placebo	Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl

Timeline

• Start date: 2020-08-11
• Primary completion: 2026-03-30
• Completion: 2026-04-05
• First posted: 2019-09-17
• Last updated: 2026-04-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study