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NCT00480740 · ClinicalTrials.gov registry record · Phase 3
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
A Phase 3 study, sponsored by Children's National Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT00480740: Completed Phase 3 study, sponsored by Children's National Research Institute.
NCT00480740 is a Phase 3 study that has completed, run by Children's National Research Institute. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00480740, a Phase 3 study, has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.
Primary Outcome
Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values. Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia.
Interventions
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2006-12 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT00480740 record still lists
NCT00480740 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Dexmedetomidine is the first listed.
NCT00480740 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00480740 about?
NCT00480740 is a clinical study titled "The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease". The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and ...
What is the current status of trial NCT00480740?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2006-12. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00480740?
The interventions under investigation include: Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT00480740?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00480740's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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