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NCT00808665 · ClinicalTrials.gov registry record · Phase 4
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
A Phase 4 study of Spinal Stenosis and Spinal Diseases, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT00808665 is a Phase 4 study of Spinal Stenosis and Spinal Diseases that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 68 participants, below the 545-participant average among 15 other Spinal Stenosis trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00808665, a Phase 4 study of Spinal Stenosis and Spinal Diseases, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
Major lumbar spine surgery causes inflammation, soreness and swelling that can delay discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory effects. This study will evaluate whether DEX can help get patients out of the hospital faster after major spine surgery by reducing the inflammation associated with the procedure itself. A separate part of the study will evaluate the blood levels of some specific indicators of inflammation called cytokines. Measuring cytokines before and after surgery will aid in determining if DEX has altered the inflammatory response.
Conditions Studied
Interventions
- DRUG Dexmedetomidine
- DRUG 0.9% Saline
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2009-06 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00808665
The ClinicalTrials.gov registry entry for NCT00808665 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 545-participant average among 15 other Spinal Stenosis trials with a reported enrollment target (88% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Spinal Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Dexmedetomidine is the first listed.
NCT00808665 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT00808665 about?
NCT00808665 is a clinical study titled "Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion". Major lumbar spine surgery causes inflammation, soreness and swelling that can delay discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory effects. This study will evaluate whether DEX can help get patients out of the hospital faster after major spine surgery by...
What is the current status of trial NCT00808665?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 68 participants. The study started on 2009-06. Estimated completion is 2012-12.
What conditions does trial NCT00808665 study?
This clinical trial studies the following conditions: Spinal Stenosis, Spinal Diseases, Spinal Fusion Acquired, Lesions of Lumbosacral Intervertebral Disc.
What interventions are being tested in trial NCT00808665?
The interventions under investigation include: Dexmedetomidine (DRUG), 0.9% Saline (DRUG).
Who is sponsoring clinical trial NCT00808665?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00808665 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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