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NCT00857727 · ClinicalTrials.gov registry record · Phase 3
Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children
A Phase 3 study of Anesthesia and Pediatrics, sponsored by St. Luke's-Roosevelt Hospital Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT00857727: Completed Phase 3 study of Anesthesia and Pediatrics, sponsored by St. Luke's-Roosevelt Hospital Center.
NCT00857727 is a Phase 3 study of Anesthesia and Pediatrics that has completed, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 33 participants, below the 109,410-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00857727, a Phase 3 study of Anesthesia and Pediatrics, has completed, sponsored by St. Luke's-Roosevelt Hospital Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical population.
Primary Outcome
Emergence Delirium (ED) during the 15-45min. post-op period as assessed by the Cole Score. (Cole Score 3-5 = ED). The Cole Scale is an ordinal ranking of ED (1=sleeping; 2=awake, calm; 3=irritable, crying; 4=inconsolable, crying; 5=severe restlessness, disorientation).
Conditions Studied
Interventions
- DRUG Saline
- DRUG Dexmedetomidine
Study Locations (1)
New York
- St Luke's-Roosevelt Hospital Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT00857727 record still lists
NCT00857727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 109,410-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Anesthesia appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT00857727 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00857727 about?
NCT00857727 is a clinical study titled "Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children". Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical population.
What is the current status of trial NCT00857727?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2009-08. Estimated completion is 2011-12.
What conditions does trial NCT00857727 study?
This clinical trial studies the following conditions: Anesthesia, Pediatrics, Agitation.
What interventions are being tested in trial NCT00857727?
The interventions under investigation include: Saline (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT00857727?
This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00857727 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00857727's enrollment target sits among peer trials
33 44th of 57 higher than 14 of 57 other Anesthesia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anesthesia 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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