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NCT01017237 · ClinicalTrials.gov registry record · Phase 4
Dexmedetomidine Sedation With Third Molar Surgery
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT01017237: Clinical Trial Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT01017237 is a Phase 4 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01017237, a Phase 4 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study Summary
Intravenous sedation is used frequently for the relief of pain and anxiety associated with oral surgical procedures performed under local anesthesia. The purpose of this study is to learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in combination with midazolam alone or with midazolam plus low dose ketamine while having wisdom teeth removed. The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital operating rooms and has been approved by the US Food and Drug Administration for the use planned in this study.
Primary Outcome
Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery
Interventions
- DRUG Ketamine
- DRUG Midazolam
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
Why NCT01017237 stopped before completion
NCT01017237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Ketamine is the first listed.
NCT01017237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01017237 about?
NCT01017237 is a clinical study titled "Dexmedetomidine Sedation With Third Molar Surgery". Intravenous sedation is used frequently for the relief of pain and anxiety associated with oral surgical procedures performed under local anesthesia. The purpose of this study is to learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in combination with midazolam alone o...
What is the current status of trial NCT01017237?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2009-07. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01017237?
The interventions under investigation include: Ketamine (DRUG), Midazolam (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT01017237?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01017237's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 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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