Status:
UNKNOWN
Oral Sedation in Vitreoretinal Surgery
Lead Sponsor:
Rocky Vista University, LLC
Conditions:
Macular Holes
Intraocular Lens Opacification
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 und...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04346095
Start Date
June 1 2020
End Date
November 1 2020
Last Update
April 15 2020
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