Delirium in Old AgePhase 3PANDORANCT04093219
PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
A Phase 3 study testing IV acetaminophen in people with Delirium in Old Age and Delirium, run by Beth Israel Deaconess Medical Center at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium in Old Age, Delirium, Coronary Artery Disease
- What is being tested?
- IV acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 901 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 Aug 2020to 5 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 60 years of age
- Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass
Who cannot join
- Pre-operative left ventricular ejection fraction (LVEF) < than 30%
- Emergent procedures
- Isolated aortic surgery
- Liver dysfunction (liver enzymes > 3 times the baseline, all patients will have a baseline liver function test information), history and exam suggestive of jaundice
- Hypersensitivity to the study drugs
- Active (in the past year) history of alcohol abuse (≥5 drinks per day for men or ≥ 4 drinks per day for women)
Show all 13Show fewer
- Any history of alcohol withdrawal or delirium tremens
- Delirium at baseline
- Non-English speaking
- Prisoners
- Physician Refusal
- COVID-19 Positive, symptomatic
- Co-enrollment with non-approved interventional trial
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of California Irvine
Irvine, California, 92697
University of California Los Angeles
Los Angeles, California, 90095
Yale University/Yale New Haven Hospital
New Haven, Connecticut, 06510
Columbia University Irving Medical Center
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Albert Einstein College of Medicine- Montefiore
The Bronx, New York, 10467
About this study
Official title: PANDORA: Scheduled Prophylactic 6-hourly Intravenous Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
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.
Read the 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;
- the incidence, duration, and severity of postoperative delirium,
- 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
- longer-term (one, six, 12 months) cognitive, physical, and self-care functional recovery after surgery.
- Conditions
- Delirium in Old Age, Delirium, Coronary Artery Disease
- Being tested
- IV acetaminophen, Placebo
- Keywords
- Acetaminophen, Postoperative, Delirium, Cardiac Surgery
- Medical subject headings
- Delirium, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV acetaminophenDrug
Also called ofirmev
use of IV tylenol for pain
PlaceboOther
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| IV Acetaminophen | Experimental | 1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively Receives: Drug: IV acetaminophen |
| Placebo | Placebo comparator | Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the CAM, 3D CAM, CAM Only, or CAM-ICU daily until hospital discharge.
Measured: Participants will be followed for the duration of the hospital stay, an average of 5 days
Secondary outcomes (13)
Incidence of Charted Delirium
Charted Delirium will be used as a key secondary outcome in addition to the CAM diagnosis. Incidence in patient's chart for diagnoses synonymous with delirium or a change to the patient's baseline mental status as indicated by trigger words associated with a predictive value for delirium
Measured: Participants will be followed for the duration of the hospital stay, an average of 5 days
Duration of delirium
Total number of in-hospital postoperative days in which delirium is present
Measured: Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery
Severity of delirium
Delirium severity is evaluated both as the peak (highest) and sum CAM-S score over all hospital days
Measured: Participants will be followed for the duration of the hospital stay, an average of 5 days
Time to onset of delirium
Measured in days
Measured: Participants will be followed for the duration of the hospital stay, an average of 5 days
Additional postoperative analgesic requirements
Amount of opioid (IV morphine or hydromorphone) and oral analgesics required for pain control, reported as overall morphine equivalents. Total Morphine Equivalent is calculated as the sum of (fentanyl dose × 2.4) + (hydromorphone dose × 4) + morphine dose + (oxycodone dose × 1.5).
Measured: First 48 hours postoperatively
Worst daily pain scores with exertion (deep breathing and cough)
Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).
Measured: Participants will be followed for the duration of the hospital stay, an average of 5 days
Length of stay in the Intensive Care Unit (ICU)
Defined by the number of days admitted in the ICU prior to transfer to the general cardiac surgical floor
Measured: Measured in days admitted in the ICU, an average of 2 days
Worst daily pain scores at rest
Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).
Measured: Participants will be followed for the duration of the hospital stay, an average of 5 days
Length of hospital stay
Defined by the number of days admitted in the hospital following the completion of surgery.
Measured: Measured in days admitted in the hospital, an average of 6 days
Trajectory of cognitive function over time
Neurocognition will be reported using the Montreal Cognitive Assessment (MoCA) score that ranges from zero (worst possible score) to 30 (best). At one, six, and twelve months postoperatively a telephonic MoCA will be assessed over the phone. The t-MoCA scores range from zero [worst] to 22 [best]. A hierarchical linear regression model will be used to characterize the trajectory of t-MoCA scores over time.
Measured: Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery
Trajectory of physical function over time.
Physical function will be assessed using the Medical Outcomes Study Short Form 12 questionnaire (SF-12) physical composite score at one, six, and twelve months postoperatively assessed over the phone. A hierarchical linear regression model will be used to characterize the trajectory of SF-12 scores over time.
Measured: Participants will be followed at 1 month, 6 month and 1- year following the date of surgery
Trajectory of functional outcomes over time
Functional status (self care) will be assessed using the FuncAQ and FRAIL scale at one, six, and twelve months postoperatively assessed over the phone. A hierarchical linear regression model will be used to characterize the trajectory of FuncAQ and FRAIL scores over time.
Measured: Participants will be followed at 1 month, 6 month and 1- year following the date of surgery
Trajectory of chronic pain over time
Chronic sternal pain will be assessed using the Numerical Pain Rating Scale (NPRS) at six and twelve months postoperatively assessed over the phone.
Measured: Participants will be followed at 6 month and 1- year following the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start11 Aug 2020
- Primary completion30 Mar 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundhar Subramaniam, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093219
- Sponsor's protocol ID
- 2019-P-000758
- Other IDs
- R01AG065554
- Acronym
- PANDORA
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 21474660Inouye 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.
PubMed 23992774Gottesman 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.
PubMed 20373345Saczynski 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.
PubMed 22762316van 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.
PubMed 22206727Gallagher R. Opioid-induced neurotoxicity. Can Fam Physician. 2007 Mar;53(3):426-7. No abstract available.
PubMed 17872676O'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.
PubMed 24350194Subramaniam 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.
PubMed 30778597Inouye 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.
PubMed 24733193Behera A, Ramachandran RV, Hussain Z, Ihalainen RJ, Orui H, Peck J, Ananthakrishnan A, Mathur P, Muehlschlegel JD, Pittet JF, Bardia A, Schonberger RB, Kveraga K, Subramaniam B. The Association of Preoperative Cognitive Dysfunction to Common Intraoperative Electroencephalographic Parameters and Cerebral Hypoxia During Cardiac Surgery. Anesth Analg. 2026 May 1;142(5):964-974. doi: 10.1213/ANE.0000000000007724. Epub 2026 Apr 14.
PubMed 41980267Ramachandran 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.
PubMed 39446661Ramachandran 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.
PubMed 38883767Khera 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.
PubMed 33692183
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANDORA: Scheduled Prophylactic 6-hourly Intravenous Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT04093219
- Acronym / sponsor ID
- PANDORA / 2019-P-000758
- Conditions
- Delirium in Old Age, Delirium, Coronary Artery Disease
- Keywords
- Acetaminophen, Postoperative, Delirium, Cardiac Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- the incidence, duration, and severity of postoperative delirium,
- 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
- longer-term (one, six, 12 months) cognitive, physical, and self-care functional recovery after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Acetaminophen | Experimental | Drug: IV acetaminophen1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively |
| Placebo | Placebo comparator | Other: PlaceboVolume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 60 years of age
- Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass
Key exclusion criteria (13 listed)
- Pre-operative left ventricular ejection fraction (LVEF) < than 30%
- Emergent procedures
- Isolated aortic surgery
- Liver dysfunction (liver enzymes > 3 times the baseline, all patients will have a baseline liver function test information), history and exam suggestive of jaundice
- Hypersensitivity to the study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV acetaminophenAlso: ofirmevuse of IV tylenol for pain | Drug | IV Acetaminophen |
| PlaceboVolume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl | Other | Placebo |
Primary outcome
Incidence of postoperative delirium
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Occurrence of delirium on any postoperative day, as assessed using the CAM, 3D CAM, CAM Only, or CAM-ICU daily until hospital discharge.
13 secondary outcomes
Incidence of Charted Delirium
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Duration of delirium
Time frame: Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery
Severity of delirium
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Time to onset of delirium
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Additional postoperative analgesic requirements
Time frame: First 48 hours postoperatively
Worst daily pain scores with exertion (deep breathing and cough)
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Length of stay in the Intensive Care Unit (ICU)
Time frame: Measured in days admitted in the ICU, an average of 2 days
Worst daily pain scores at rest
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Length of hospital stay
Time frame: Measured in days admitted in the hospital, an average of 6 days
Trajectory of cognitive function over time
Time frame: Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery
Trajectory of physical function over time.
Time frame: Participants will be followed at 1 month, 6 month and 1- year following the date of surgery
Trajectory of functional outcomes over time
Time frame: Participants will be followed at 1 month, 6 month and 1- year following the date of surgery
Trajectory of chronic pain over time
Time frame: Participants will be followed at 6 month and 1- year following the date of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 21474660Rudolph 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.
- Background: PubMed 23992774Inouye 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.
- Background: PubMed 20373345Gottesman 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.
- Background: PubMed 22762316Saczynski 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.
- Background: PubMed 22206727van 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.
- Background: PubMed 17872676Gallagher R. Opioid-induced neurotoxicity. Can Fam Physician. 2007 Mar;53(3):426-7. No abstract available.
- Background: PubMed 24350194O'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.
- Background: PubMed 30778597Subramaniam 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.
- Background: PubMed 24733193Inouye 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.
- Derived from this study: PubMed 41980267Behera A, Ramachandran RV, Hussain Z, Ihalainen RJ, Orui H, Peck J, Ananthakrishnan A, Mathur P, Muehlschlegel JD, Pittet JF, Bardia A, Schonberger RB, Kveraga K, Subramaniam B. The Association of Preoperative Cognitive Dysfunction to Common Intraoperative Electroencephalographic Parameters and Cerebral Hypoxia During Cardiac Surgery. Anesth Analg. 2026 May 1;142(5):964-974. doi: 10.1213/ANE.0000000000007724. Epub 2026 Apr 14.
- Derived from this study: PubMed 39446661Ramachandran 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.
- Derived from this study: PubMed 38883767Ramachandran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balachundhar Subramaniam, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV acetaminophen in people with Delirium in Old Age and Delirium, run by Beth Israel Deaconess Medical Center at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093219, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.