Oral Versus Intravenous Sedation for Ocular Procedures
Condition: Surgery; Sedation
Intervention: Triazolam; Midazolam; Microcrystalline Cellulose; Sodium chloride 0.9%
Intervention description: This will be used for oral sedation. This capsule or a microcrystalline cellulose placebo capsule will be administered depending on the randomized treatment group.
Dose for BMI less than 35: 0.125 mg
Dose for BMI greater than or equal to 35: 0.25 mg; This will be used for intravenous sedation. This injection or sodium chloride 0.9% will be administered depending on the randomized treatment group.
Dose for BMI less than 35: 1.0 mg
Dose for BMI greater than or equal to 35: 2.0 mg; This will be used for the oral placebo. This capsule or a triazolam capsule will be administered depending on the randomized treatment group.
Dose for BMI less than 35: 1 capsule
Dose for BMI greater than or equal to 35: 2 capsule; This will be used for the intravenous placebo.This injection or midazolam will be administered depending on the randomized treatment group.
Dose for BMI less than 35: volume to match volume of active intravenous medication
Dose for BMI greater than or equal to 35: volume to match volume of active intravenous medication
Intervention MeSH terms: Midazolam; Triazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventions: triazolam oral sedation with sodium chloride 0.9% IV placebo or microcrystalline cellulose oral placebo with midazolam IV sedation
Subjects will be randomized (1:1) to one of the two study arms listed above. On the day of surgery, the subject, anesthesiologist/CRNA, and surgeon will be blinded to the treatment assignment. The anesthesiologist/CRNA or pre-operative nurses will administer the blinded oral medication approximately 30 minutes before the procedure beings. The anesthesiologist/CRNA will administer the blinded IV medication approximately 5 minutes before the procedure begins. At the completion of the procedure, the anesthesiologist/CRNA and the surgeon will complete a satisfaction survey. The subject will then return within 2 days for their first post-operative clinical visit and complete a satisfaction survey.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The subject and their entire medical team (including the anesthesiologist and surgeon) will all be masked to the subject's randomized intervention group. The randomization groups will be assigned by the statistician who will be unmasked. All medications will be provided to the medical team on the day of the procedure completely masked. The clinical research coordinator, the clinical research assistant, and the pharmacy will be unmasked to the intervention group. Any member of the medical team can be unmasked at any time after the intervention is administered in the case of an emergency resulting in a serious adverse event or an unanticipated problem.
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular surgery; Intravenous sedation; Oral sedation

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).
    

Eligibility 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