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NCT01195103 · ClinicalTrials.gov registry record · Phase 4
Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
A Phase 4 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT01195103: Clinical Trial Phase 4 study, sponsored by Mayo Clinic.
NCT01195103 is a Phase 4 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 13 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
NCT01195103, a Phase 4 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
Primary Outcome
Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals "lethargic response to name spoken in normal tone."
Interventions
- DRUG Fentanyl
- DRUG Fospropofol disodium
- DRUG Placebo + Midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
Why NCT01195103 stopped before completion
NCT01195103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 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 Fentanyl is the first listed.
NCT01195103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01195103 about?
NCT01195103 is a clinical study titled "Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery". How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
What is the current status of trial NCT01195103?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2011-02. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01195103?
The interventions under investigation include: Fentanyl (DRUG), Fospropofol disodium (DRUG), Placebo + Midazolam (DRUG).
Who is sponsoring clinical trial NCT01195103?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01195103's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 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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