Status:
COMPLETED
Oral Versus Intravenous Sedation for Ocular Procedures
Lead Sponsor:
Boston Medical Center
Conditions:
Surgery
Sedation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The primary objective of this study is to compare patient satisfaction of oral triazolam to IV midazolam when administered for ocular procedures. Midazolam is an FDA-approved intravenous medication co...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Ability to speak and read in English or Spanish or Haitian Creole
- Subjects able to consent for themselves
- Outpatient surgical plan for any of the following procedures:
- Cataract surgery: cataracts
- Retina: pars plana vitrectomy, pars plana vitrectomy with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal
- Cornea: descemet stripping endothelial keratopathy, cataracts with descemet stripping endothelial keratopathy, descemet membrane endothelial keratoplasty, cataracts with descemet membrane endothelial keratoplasty, conjunctival and/or corneal lesion excisions, pterygium
- Glaucoma: ahmed valve, ahmed valve with cataracts,trabeculectomy, trabeculectomy with cataracts, baerveldt, baerveldt with cataracts, endocyclophotocoagulation, endocyclophotocoagulation with cataracts, istent, istent with cataracts, kahook, kahook with cataracts, cypass, cypass with cataracts
Exclusion
- Surgical plan which includes general anesthesia
- Hypersensitivity or allergy to benzodiazepines
- Women who are pregnant, have a positive pregnancy test on the day of surgery, refuse a pregnancy test, or are nursing
- Previous delirium after anesthesia with a benzodiazepine
- Subjects 70 years of age or older who fail the delirium pre-screening questionnaire as shown in Appendix Section 15.6
- Currently experiencing the effects of drug/alcohol
- Current oral/IV regimen of any medication inhibiting cytochrome P450 3A which includes ketoconazole, itraconazole, nefazodone, ritonavir, indinavir, nelavir, saquinavir, and lopinavir
- Subjects already enrolled in this study for the fellow eye
- Subjects enrolled in a clinical trial with an investigational drug within the past 3 months
- Failed anesthesia clearance to receive a benzodiazepine
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT03246724
Start Date
October 16 2017
End Date
November 30 2019
Last Update
August 19 2020
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118