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Comparative Analysis of Oral Sedation Versus Standard Intravenous Sedation in Vitreoretinal Surgery With Topical Anesthesia and Sub-tenon's Block
The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.
Details
| Lead sponsor | Rocky Vista University, LLC |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 80 |
| Start date | 2020-06 |
| Completion | 2020-11 |
Conditions
- Macular Holes
- Intraocular Lens Opacification
- Vitrectomy
- Vitreous Hemorrhage
- Retinal Detachment
- Epiretinal Membrane
- Vitreous Detachment
- Intraocular Lens Dislocation
Interventions
- Oral Sedatives with or Without Analgesia
- Intravenous Sedatives with or Without Analgesia
Primary outcomes
- Patient satisfaction: scale — A patient satisfaction survey will be completed at the one-day post operative appointment.
The patient will complete a survey at the one-day post-operative appointment. The survey consists of statements regarding the surgical procedure and experience with a scale of 1 to 6 demonstrating the patient's agreement or disagreement with the statement. Additional questions regarding the surgery and not using the 1 to 6 model will also be asked in the same survey. There will be 14 questions in the 1-6 scale portion of the survey and 4 additional questions. After all questions have been answered, the scaled questions will be analyzed for an average score out of 6 per patient. Additional questions will be analyzed by percentage of each answer. The scaled questions will be used to determine the non-inferiority of the experimental treatment. Additional questions will not be included in the non-inferiority analysis but results will be included in the study.