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NCT03246724 · ClinicalTrials.gov registry record · Phase 4
Oral Versus Intravenous Sedation for Ocular Procedures
A Phase 4 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 327
- Enrollment target
NCT03246724: Completed Phase 4 study, sponsored by Boston Medical Center.
NCT03246724 is a Phase 4 study that has completed, run by Boston Medical Center. The registered enrollment target is 327 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03246724, a Phase 4 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 327 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate patient satisfaction after eye surgery when given a capsule compared to an intravenous (IV) dose of sedation (calming medication). Each subject will be given a capsule and an IV in the hospital before their procedure starts, however they will not know which one is the sedation route. Each subject will have their planned surgical procedure as previously discussed with their doctor. After the procedure is completed, the doctors will complete satisfaction surveys. The subject will also complete a satisfaction survey during their regularly scheduled visit the day after surgery. Once the subject completes this survey, their study participation will be complete. The hypothesis is that there will be no difference in patient satisfaction when given a capsule in comparison to IV sedation. If the results of the study support this hypothesis, a capsule could be used in place of IV sedation. By using a capsule for ocular procedures, both patients and the medical practice would benefit: patient would be able to eat before their procedure, patient costs would be decreased, hospital costs would be reduced, and some of these procedures would be given the option to move to a procedure room (freeing up operating room time for other departments).
Primary Outcome
Patient satisfaction will be determined by completion of a 12 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per patient. Higher mean scores are associated with higher levels of satisfaction.
Interventions
- DRUG Midazolam
- DRUG Triazolam
- DRUG Microcrystalline Cellulose
- DRUG Sodium chloride 0.9%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2019-11-30 |
| Phase | Phase 4 |
What the finished NCT03246724 record still lists
NCT03246724 is an interventional study that assigns participants to a tested intervention. The registered 327 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 (37% lower).
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT03246724 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03246724 about?
NCT03246724 is a clinical study titled "Oral Versus Intravenous Sedation for Ocular Procedures". The purpose of this study is to evaluate patient satisfaction after eye surgery when given a capsule compared to an intravenous (IV) dose of sedation (calming medication). Each subject will be given a capsule and an IV in the hospital before their procedure starts, however they will not know which ...
What is the current status of trial NCT03246724?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 327 participants. The study started on 2017-10-16. Estimated completion is 2019-11-30.
What interventions are being tested in trial NCT03246724?
The interventions under investigation include: Midazolam (DRUG), Triazolam (DRUG), Microcrystalline Cellulose (DRUG), Sodium chloride 0.9% (DRUG).
Who is sponsoring clinical trial NCT03246724?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03246724's enrollment target sits among peer trials
327 253rd of 2000 higher than 1,748 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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