Oral Versus Intravenous Sedation for Ocular Procedures

• Status: Completed
• Trial end date: 2019-11-30
• Target enrollment: 0
• Participant gender: All

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 a capsule and an IV in the hospital before their procedure starts, however they will not know which one is the sedation route. Each subject will have their planned surgical procedure as previously discussed with their doctor. After the procedure is completed, the doctors will complete satisfaction surveys. The subject will also complete a satisfaction survey during their regularly scheduled visit the day after surgery. Once the subject completes this survey, their study participation will be complete.

The hypothesis is that there will be no difference in patient satisfaction when given a capsule in comparison to IV sedation. If the results of the study support this hypothesis, a capsule could be used in place of IV sedation. By using a capsule for ocular procedures, both patients and the medical practice would benefit: patient would be able to eat before their procedure, patient costs would be decreased, hospital costs would be reduced, and some of these procedures would be given the option to move to a procedure room (freeing up operating room time for other departments).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Treatments: Midazolam; Triazolam

Criteria

Inclusion Criteria:

1. Age 18 years or older

2. Ability to speak and read in English or Spanish or Haitian Creole

3. Subjects able to consent for themselves

4. 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 Criteria:

1. Surgical plan which includes general anesthesia

2. Hypersensitivity or allergy to benzodiazepines

3. Women who are pregnant, have a positive pregnancy test on the day of surgery, refuse a pregnancy test, or are nursing

4. Previous delirium after anesthesia with a benzodiazepine

5. Subjects 70 years of age or older who fail the delirium pre-screening questionnaire as shown in Appendix Section 15.6

6. Currently experiencing the effects of drug/alcohol

7. Current oral/IV regimen of any medication inhibiting cytochrome P450 3A which includes ketoconazole, itraconazole, nefazodone, ritonavir, indinavir, nelavir, saquinavir, and lopinavir

8. Subjects already enrolled in this study for the fellow eye

9. Subjects enrolled in a clinical trial with an investigational drug within the past 3 months

10. Failed anesthesia clearance to receive a benzodiazepine