Oral Versus Intravenous Sedation for Ocular Procedures
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/27/2019 |
| Start Date: | October 16, 2017 |
| End Date: | August 2019 |
| Contact: | Manju Subramanian, MD |
| Email: | Manju.Subramanian@bmc.org |
| Phone: | 617-638-4555 |
A Single-center, Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing Oral Sedation to Intravenous Sedation for Ocular Procedures.
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).
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).
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 commonly used as a sedative for ocular procedures conducted in the
operating room. This study will compare the use of triazolam, an FDA-approved oral sedative
for the same types of ocular procedures, a purpose which has not fully been investigated. The
benzodiazepine triazolam was chosen as the oral medication due to its similarity to
midazolam. The similarities between midazolam and triazolam include similar half-life, risks,
and patient experience.The medication doses were chosen from current SOC use based on weight.
The lower dose for both medications are used for patients with a BMI less than 35 and the
higher dose is used for patients with a BMI greater than or equal to 35.
This is the first double-blind, prospective clinical trial that will compare IV and oral
sedation for multiple ocular sub-specialty procedures. The procedures to be investigated
include: cataract, retina, cornea, and glaucoma surgical groups.
IV midazolam when administered for ocular procedures. Midazolam is an FDA-approved
intravenous medication commonly used as a sedative for ocular procedures conducted in the
operating room. This study will compare the use of triazolam, an FDA-approved oral sedative
for the same types of ocular procedures, a purpose which has not fully been investigated. The
benzodiazepine triazolam was chosen as the oral medication due to its similarity to
midazolam. The similarities between midazolam and triazolam include similar half-life, risks,
and patient experience.The medication doses were chosen from current SOC use based on weight.
The lower dose for both medications are used for patients with a BMI less than 35 and the
higher dose is used for patients with a BMI greater than or equal to 35.
This is the first double-blind, prospective clinical trial that will compare IV and oral
sedation for multiple ocular sub-specialty procedures. The procedures to be investigated
include: cataract, retina, cornea, and glaucoma surgical groups.
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
We found this trial at
1
site
Boston, Massachusetts 02118
Principal Investigator: Manju Subramanian, MD
Phone: 617-414-8848
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