NCT04346095

Oral Sedation in Vitreoretinal Surgery

Comparative Analysis of Oral Sedation Versus Standard Intravenous Sedation in Vitreoretinal Surgery With Topical Anesthesia and Sub-tenon's Block

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Rocky Vista University, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.

Detailed description

After being informed about the study and potential risks, and providing written informed consent, a total of 40 patients will undergo vitreoretinal surgery with oral Triazolam and 40 patients will undergo vitreoretinal surgery with intravenous sedation. The IV sedative will be determined by the anesthesiologist or certified registered nurse anesthetist but limited to midazolam, propofol, and fentanyl. The study will be a prospective, cross-sectional study with a 1:1 randomized procedure and unmasked.

Conditions

• Macular Holes
• Intraocular Lens Opacification
• Vitrectomy
• Vitreous Hemorrhage
• Retinal Detachment
• Epiretinal Membrane
• Vitreous Detachment
• Intraocular Lens Dislocation

Interventions

Type	Name	Description
DRUG	Oral Sedatives with or Without Analgesia	The participants will receive oral triazolam with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.
DRUG	Intravenous Sedatives with or Without Analgesia	The participants will receive intravenous midazolam, propofol or fentanyl with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-10-01
• Completion: 2020-11-01
• First posted: 2020-04-15
• Last updated: 2020-04-15

Regulatory

• FDA-regulated drug study