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NCT02546765 · ClinicalTrials.gov registry record · Phase 4
Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
NCT02546765: Completed Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
NCT02546765 is a Phase 4 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02546765, a Phase 4 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
Study Summary
Investigators will assess the incidence and duration of postoperative delirium in patients ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia. Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or standard postoperative management using IV propofol with morphine or hydromorphone. The Confusion Assessment Method (CAM) will be used to assess delirium in these patients. Investigators also seek to compare postoperative (48 hours) analgesic requirements in patients with or without IV acetaminophen. Investigators will finally assess postoperative cognition in post-surgical patients up to one year post-discharge using a cognitive assessment scale.
Primary Outcome
Incidence of delirium will be analyzed between patients treated with and without IV acetaminophen, measured from 24 hours post-operation and daily until discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM).
Interventions
- DRUG IV acetaminophen & IV propofol
- DRUG IV acetaminophen & IV dexmedetomidine
- DRUG IV propofol & placebo
- DRUG IV dexmedetomidine & placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-10 |
| Est. Completion | 2019-07 |
| Phase | Phase 4 |
What the finished NCT02546765 record still lists
NCT02546765 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which IV acetaminophen & IV propofol is the first listed.
NCT02546765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02546765 about?
NCT02546765 is a clinical study titled "Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery". Investigators will assess the incidence and duration of postoperative delirium in patients ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia. Patients will receive ei...
What is the current status of trial NCT02546765?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2015-10. Estimated completion is 2019-07.
What interventions are being tested in trial NCT02546765?
The interventions under investigation include: IV acetaminophen & IV propofol (DRUG), IV acetaminophen & IV dexmedetomidine (DRUG), IV propofol & placebo (DRUG), IV dexmedetomidine & placebo (DRUG).
Who is sponsoring clinical trial NCT02546765?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02546765's enrollment target sits among peer trials
140 581st of 2000 higher than 1,408 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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