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NCT01401049 · ClinicalTrials.gov registry record · Phase 4
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 116
- Enrollment target
NCT01401049: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT01401049 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 116 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01401049, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 116 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).
Primary Outcome
We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.
Interventions
- DRUG Fospropofol
- DRUG Propofol/Lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT01401049 record still lists
NCT01401049 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Fospropofol is the first listed.
NCT01401049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01401049 about?
NCT01401049 is a clinical study titled "Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol". The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used w...
What is the current status of trial NCT01401049?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 116 participants. The study started on 2010-08. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01401049?
The interventions under investigation include: Fospropofol (DRUG), Propofol/Lidocaine (DRUG).
Who is sponsoring clinical trial NCT01401049?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01401049's enrollment target sits among peer trials
116 714th of 2000 higher than 1,283 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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