PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
NCT ID: NCT04093219
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
900 participants
INTERVENTIONAL
2020-08-11
2026-03-04
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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IV Acetaminophen
1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively
IV acetaminophen
use of IV tylenol for pain
Placebo
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
Placebo
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
Interventions
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IV acetaminophen
use of IV tylenol for pain
Placebo
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients undergoing cardiac surgery \[coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery\] requiring cardiopulmonary bypass
Exclusion Criteria
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 (≥5 drinks per day for men or ≥ 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
60 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Balachundhar Subramaniam
Associate Professor of Anesthesia
Principal Investigators
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Balachundhar Subramaniam, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Irvine
Irvine, California, United States
University of California Los Angeles
Los Angeles, California, United States
Yale University/Yale New Haven Hospital
New Haven, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
Albert Einstein College of Medicine- Montefiore
The Bronx, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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References
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Gallagher R. Opioid-induced neurotoxicity. Can Fam Physician. 2007 Mar;53(3):426-7. No abstract available.
O'Neal JB. The utility of intravenous acetaminophen in the perioperative period. Front Public Health. 2013 Aug 6;1:25. doi: 10.3389/fpubh.2013.00025.
van den Boogaard M, Kox M, Quinn KL, van Achterberg T, van der Hoeven JG, Schoonhoven L, Pickkers P. Biomarkers associated with delirium in critically ill patients and their relation with long-term subjective cognitive dysfunction; indications for different pathways governing delirium in inflamed and noninflamed patients. Crit Care. 2011;15(6):R297. doi: 10.1186/cc10598. Epub 2011 Dec 29.
Rudolph JL, Marcantonio ER. Review articles: postoperative delirium: acute change with long-term implications. Anesth Analg. 2011 May;112(5):1202-11. doi: 10.1213/ANE.0b013e3182147f6d. Epub 2011 Apr 7.
Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
Gottesman RF, Grega MA, Bailey MM, Pham LD, Zeger SL, Baumgartner WA, Selnes OA, McKhann GM. Delirium after coronary artery bypass graft surgery and late mortality. Ann Neurol. 2010 Mar;67(3):338-44. doi: 10.1002/ana.21899.
Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
Subramaniam B, Shankar P, Shaefi S, Mueller A, O'Gara B, Banner-Goodspeed V, Gallagher J, Gasangwa D, Patxot M, Packiasabapathy S, Mathur P, Eikermann M, Talmor D, Marcantonio ER. Effect of Intravenous Acetaminophen vs Placebo Combined With Propofol or Dexmedetomidine on Postoperative Delirium Among Older Patients Following Cardiac Surgery: The DEXACET Randomized Clinical Trial. JAMA. 2019 Feb 19;321(7):686-696. doi: 10.1001/jama.2019.0234.
Inouye SK, Kosar CM, Tommet D, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Jones RN. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014 Apr 15;160(8):526-533. doi: 10.7326/M13-1927.
Ramachandran RV, Behera A, Hussain Z, Peck J, Ananthakrishanan A, Mathur P, Banner-Goodspeed V, Muehlschlegel JD, Pittet JF, Bardia A, Schonberger R, Marcantonio ER, Kveraga K, Subramaniam B. Incidence of Concurrent Cerebral Desaturation and Electroencephalographic Burst Suppression in Cardiac Surgery Patients. Anesth Analg. 2025 May 1;140(5):1086-1092. doi: 10.1213/ANE.0000000000007209.
Ramachandran RV, Ananthakrishnan A, Orui H, Kveraga K, Subramaniam B. The Influence of Preoperative Physical Activity on Intraoperative Brain Function in Cardiac Surgical patients. Res Sq [Preprint]. 2024 Jun 7:rs.3.rs-4427122. doi: 10.21203/rs.3.rs-4427122/v1.
Khera T, Mathur PA, Banner-Goodspeed VM, Narayanan S, Mcgourty M, Kelly L, Palihnich K, Novack L, Davis R, Talmor D, Marcantonio ER, Subramaniam B. Scheduled Prophylactic 6-Hourly IV AcetaminopheN to Prevent Postoperative Delirium in Older CaRdiac SurgicAl Patients (PANDORA): protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Mar 10;11(3):e044346. doi: 10.1136/bmjopen-2020-044346.
Other Identifiers
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2019-P-000758
Identifier Type: -
Identifier Source: org_study_id
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