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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 is a Phase 4 study that has completed, run by Boston Medical Center. The registered enrollment target is 327 participants.

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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).

Interventions

  • DRUG Midazolam
  • DRUG Triazolam
  • DRUG Microcrystalline Cellulose
  • DRUG Sodium chloride 0.9%

Trial Details

FieldValue
Enrollment Target 327 participants
Start Date 2017-10-16
Est. Completion 2019-11-30
Phase Phase 4

Sponsor

Boston Medical Center

253 total trials

What the Registry Record Tells You About NCT03246724

The ClinicalTrials.gov registry entry for NCT03246724 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 327 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.

NCT03246724 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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