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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 is a Phase 4 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 140 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02546765
The ClinicalTrials.gov registry entry for NCT02546765 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which IV acetaminophen & IV propofol is the first listed.
NCT02546765 reports 0 study locations.
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.
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