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NCT00561678 · ClinicalTrials.gov registry record · Phase 4
Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 4
- Development phase
- 404
- Enrollment target
NCT00561678: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT00561678 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 404 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00561678, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 404 participants
- Enrollment target
Study Summary
Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration of brain function including the development of postoperative delirium (PD) and postoperative cognitive dysfunction (POCD). These disorders cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use relatively primitive approaches to preventing and treating PD and POCD. Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.
Primary Outcome
Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU)
Interventions
- DRUG Placebo
- DRUG Precedex (Dexmedetomidine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2008-02 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
What the finished NCT00561678 record still lists
NCT00561678 is an interventional study that assigns participants to a tested intervention. The registered 404 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 (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00561678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00561678 about?
NCT00561678 is a clinical study titled "Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve". Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration of brain function including the development of postoperative delirium (PD) and postoperative cognitive dysfunction (POCD). These disorders cause disability, distress for both patients and their families, are...
What is the current status of trial NCT00561678?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 404 participants. The study started on 2008-02. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00561678?
The interventions under investigation include: Placebo (DRUG), Precedex (Dexmedetomidine) (DRUG).
Who is sponsoring clinical trial NCT00561678?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00561678's enrollment target sits among peer trials
404 209th of 2000 higher than 1,791 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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