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NCT01976845 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 139
- Enrollment target
NCT01976845: Completed Phase 4 study, sponsored by Cedars-Sinai Medical Center.
NCT01976845 is a Phase 4 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 139 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01976845, a Phase 4 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 139 participants
- Enrollment target
Study Summary
The purpose of this research is: To evaluate the sedative (reduces irritability or agitation), anxiolytic (reduces anxiety), and amnesic (produces temporary lack of recall) effects of propofol or midazolam when administered for preoperative medication (before administration of drugs that will put patient to sleep) in comparison to placebo. This study is to test whether the use of the pre-anesthesia medication measurably reduces anxiety in comparison to receiving no pre-anesthesia medication prior to orthopedic procedures. To assess the effect of propofol in comparison to placebo and midazolam on the ability to recall (memory of): * when the doctor places the mask on patient's face prior to going to sleep * recall of 2 pictures * on your satisfaction with the anesthesia as well as postoperative side effects in post-anesthesia care unit (PACU) e.g., nausea ,vomiting and sedation.
Primary Outcome
Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely nervous)
Interventions
- DRUG Midazolam
- DRUG Saline
- DRUG Propofol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-07 |
| Phase | Phase 4 |
What the finished NCT01976845 record still lists
NCT01976845 is an interventional study that assigns participants to a tested intervention. The registered 139 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 (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT01976845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01976845 about?
NCT01976845 is a clinical study titled "Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication". The purpose of this research is: To evaluate the sedative (reduces irritability or agitation), anxiolytic (reduces anxiety), and amnesic (produces temporary lack of recall) effects of propofol or midazolam when administered for preoperative medication (before administration of drugs that will put p...
What is the current status of trial NCT01976845?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 139 participants. The study started on 2013-11. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01976845?
The interventions under investigation include: Midazolam (DRUG), Saline (DRUG), Propofol (DRUG).
Who is sponsoring clinical trial NCT01976845?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01976845's enrollment target sits among peer trials
139 593rd of 2000 higher than 1,408 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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