Oral Sedation in Vitreoretinal Surgery

• Status: Not yet recruiting
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rocky Vista University, LLC
• Treatments: Hypnotics and Sedatives

Criteria

Inclusion Criteria:

• Undergoing vitreoretinal surgery for a variety of indications including, but not limited to, epiretinal membrane (ERM), macular hole, vitreous opacities, vitreous hemorrhage, aphakia, dislocated or displaced intraocular or crystalline lens, silicone removal, endolaser, and retinal detachment.

• American Society of Anesthesiologists rating of I-III

Exclusion Criteria:

• Undergoing vitreoretinal surgery requiring general anesthesia

• Allergy or hypersensitivity to benzodiazepines

• Pregnant or nursing females

• Previous delirium after anesthesia

• Current use of drug or alcohol on the day of surgery

• Currently on medications inhibiting cytochrome P450

• Failed anesthesia clearance

• Reported anxiety or a history of anxiolytic use

• Vitreoretinal surgery performed within the last 3 months of the current procedure

• Impaired renal or liver function