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NCT02111447 · ClinicalTrials.gov registry record · Phase 4
Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI
A Phase 4 study, sponsored by State University of New York at Buffalo.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT02111447: Clinical Trial Phase 4 study, sponsored by State University of New York at Buffalo.
NCT02111447 is a Phase 4 study that was terminated before completion, run by State University of New York at Buffalo. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02111447, a Phase 4 study, was terminated before completion, sponsored by State University of New York at Buffalo.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during MRI to obviate the contribution of pain during emergence. Airway complications have been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs. Whether the airway complications were due to the LMA or the isoflurane was unclear. Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with IV propofol and 2. airway complications after LMA or nasal prongs.
Primary Outcome
Delirium on emergence will be assessed using the PAED scale by a blinded observer in the post anesthesia period. A score \>12 constitutes a diagnosis of delirium in children. The post anesthesia period is usually \<2 hours after anesthesia.
Interventions
- DRUG Sevoflurane
- DRUG Propofol
- DRUG Isoflurane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
Why NCT02111447 stopped before completion
NCT02111447 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Sevoflurane is the first listed.
NCT02111447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02111447 about?
NCT02111447 is a clinical study titled "Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI". Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish...
What is the current status of trial NCT02111447?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2014-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02111447?
The interventions under investigation include: Sevoflurane (DRUG), Propofol (DRUG), Isoflurane (DRUG).
Who is sponsoring clinical trial NCT02111447?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02111447's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 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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