Oral Versus Intravenous Sedation for Ocular Procedures
Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03246724
Collaborator
(none)
327
1
4
25.5
12.8
Study Details
Study Description
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 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
327 participants
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.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.
Primary Purpose:
Health Services Research
Official Title:
A Single-center, Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing Oral Sedation to Intravenous Sedation for Ocular Procedures.
Actual Study Start Date
:
Oct 16, 2017
Actual Primary Completion Date
:
Nov 30, 2019
Actual Study Completion Date
:
Nov 30, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cataract Procedures The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
Drug: Triazolam
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
Other Names:
Drug: Midazolam
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
Other Names:
Drug: Microcrystalline Cellulose
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
Other Names:
Drug: Sodium chloride 0.9%
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
Other Names:
|
| Experimental: Retina Procedures The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy Pars plana vitrectomy with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
Drug: Triazolam
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
Other Names:
Drug: Midazolam
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
Other Names:
Drug: Microcrystalline Cellulose
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
Other Names:
Drug: Sodium chloride 0.9%
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
Other Names:
|
| Experimental: Cornea Procedures The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with Descemet Stripping Endothelial Keratoplasty (DSEK) Descemet Membrane Endothelial Keratoplasty (DMEK) Cataracts with Descemet Membrane Endothelial Keratoplasty (DMEK) Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
Drug: Triazolam
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
Other Names:
Drug: Midazolam
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
Other Names:
Drug: Microcrystalline Cellulose
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
Other Names:
Drug: Sodium chloride 0.9%
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
Other Names:
|
| Experimental: Glaucoma Procedures The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation Endocyclophotocoagulation with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
Drug: Triazolam
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
Other Names:
Drug: Midazolam
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
Other Names:
Drug: Microcrystalline Cellulose
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
Other Names:
Drug: Sodium chloride 0.9%
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Patient Satisfaction [The patient satisfaction survey was administered up to two days after surgery.]
Patient satisfaction will be determined by completion of a 12 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per patient. Higher mean scores are associated with higher levels of satisfaction.
Secondary Outcome Measures
- Surgeon Satisfaction [The surgeon satisfaction survey will be administered immediately after the completion of the surgery. .]
Surgeon satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per surgeon Higher mean scores are associated with higher levels of satisfaction.
- Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction [The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case.]
Anesthesiologist/CRNA satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per anesthesiologist/CRNA. Higher mean scores are associated with higher levels of satisfaction.
Other Outcome Measures
- Number of Participants Requiring Additional Anesthesia Intervention [Information regarding additional anesthesia intervention will be collected within 2 days of completion of the subjects surgical procedure.]
The number of subjects in each arm that received additional anesthetic agents during the operative procedure after the initial sedation.
- Surgical Complication Rates [Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure.]
The number of subjects in each arm that experienced a complication during the operative procedure after the initial sedation.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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 Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
Sponsors and Collaborators
- Boston Medical Center
Investigators
- Principal Investigator: Manju Subramanian, MD, Boston Medical Center
Study Documents (Full-Text)
More Information
Additional Information:
- Midazolam Drug Label Information
- Commercial Insurance Costs Savings in Ambulatory Surgery Center 2016
Publications
- American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9.
- Campbell J. Intravenous cannulation: potential complications. Prof Nurse. 1997 May;12(8 Suppl):S10-3. Review.
- Committee on Standards and Practice Parameters, Apfelbaum JL, Connis RT, Nickinovich DG; American Society of Anesthesiologists Task Force on Preanesthesia Evaluation, Pasternak LR, Arens JF, Caplan RA, Connis RT, Fleisher LA, Flowerdew R, Gold BS, Mayhew JF, Nickinovich DG, Rice LJ, Roizen MF, Twersky RS. Practice advisory for preanesthesia evaluation: an updated report by the American Society of Anesthesiologists Task Force on Preanesthesia Evaluation. Anesthesiology. 2012 Mar;116(3):522-38. doi: 10.1097/ALN.0b013e31823c1067.
- Ianchulev T, Litoff D, Ellinger D, Stiverson K, Packer M. Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States. Ophthalmology. 2016 Apr;123(4):723-8. doi: 10.1016/j.ophtha.2015.12.020. Epub 2016 Jan 22.
Responsible Party:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT03246724
Other Study ID Numbers:
- H-36590
First Posted:
Aug 11, 2017
Last Update Posted:
Aug 19, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Boston Medical Center
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients were recruited from October 26th, 2017 to November 30th, 2019 at the outpatient eye clinic, Ophthalmology Department, Boston Medical Center. |
|---|---|
| Pre-assignment Detail | Out of 327 patients enrolled, 283 completed study participation and 44 patients did not complete study participation as they were dropped or withdrew from the study. 22 patients were dropped before randomization and 22 patients discontinued from study after randomization due to reasons seen in the participant flow table. |
| Arm/Group Title | Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures |
|---|---|---|---|---|
| Arm/Group Description | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy (PPV) PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with DSEK Descemet Membrane Endothelial Keratoplasty (DMEK) Cataracts with DMEK Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation Endocyclophotocoagulation with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Period Title: Overall Study | ||||
| STARTED | 99 | 91 | 85 | 52 |
| COMPLETED | 85 | 84 | 70 | 44 |
| NOT COMPLETED | 14 | 7 | 15 | 8 |
Baseline Characteristics
| Arm/Group Title | Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures | Total |
|---|---|---|---|---|---|
| Arm/Group Description | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation Triazolam or microcrystalline cellulose oral placebo: Administered 30 minutes prior to surgery. Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg | The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy Pars plana vitrectomy with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation Triazolam or microcrystalline cellulose oral placebo: Administered 30 minutes prior to surgery. Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg | The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with DSEK Descemet Membrane Endothelial Keratoplasty(DMEK) Cataracts with DMEK Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation Triazolam or oral placebo: Administered 30 minutes prior to surgery Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg | The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation (ECP) ECP with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% IV placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation Triazolam or placebo: Given 30 minutes prior to surgery Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg Midazolam or placebo: Given 5 minutes prior to surgery Dose for BMI less than 35: 1. | Total of all reporting groups |
| Overall Participants | 85 | 84 | 70 | 44 | 283 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
64.59
(9.14)
|
57.02
(12.65)
|
49.96
(14.99)
|
66.52
(11.32)
|
59.67
(13.96)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
43
50.6%
|
38
45.2%
|
23
32.9%
|
20
45.5%
|
124
43.8%
|
| Male |
42
49.4%
|
46
54.8%
|
47
67.1%
|
24
54.5%
|
159
56.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
27
31.8%
|
21
25%
|
42
60%
|
8
18.2%
|
98
34.6%
|
| Not Hispanic or Latino |
58
68.2%
|
60
71.4%
|
26
37.1%
|
32
72.7%
|
176
62.2%
|
| Unknown or Not Reported |
0
0%
|
3
3.6%
|
2
2.9%
|
4
9.1%
|
9
3.2%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
1.4%
|
0
0%
|
1
0.4%
|
| Asian |
0
0%
|
1
1.2%
|
0
0%
|
1
2.3%
|
2
0.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
1.2%
|
0
0%
|
0
0%
|
1
0.4%
|
| Black or African American |
34
40%
|
28
33.3%
|
19
27.1%
|
28
63.6%
|
109
38.5%
|
| White |
22
25.9%
|
25
29.8%
|
9
12.9%
|
2
4.5%
|
58
20.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
29
34.1%
|
29
34.5%
|
41
58.6%
|
13
29.5%
|
112
39.6%
|
| Language (Count of Participants) | |||||
| English |
51
60%
|
56
66.7%
|
25
35.7%
|
26
59.1%
|
158
55.8%
|
| Spanish |
26
30.6%
|
20
23.8%
|
42
60%
|
9
20.5%
|
97
34.3%
|
| Haitian Creole |
8
9.4%
|
8
9.5%
|
3
4.3%
|
9
20.5%
|
28
9.9%
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kg/m^2] |
31.12
(6.44)
|
29.86
(6.1)
|
29.91
(5.48)
|
29.6
(5.94)
|
29.77
(5.94)
|
Outcome Measures
| Title | Patient Satisfaction |
|---|---|
| Description | Patient satisfaction will be determined by completion of a 12 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per patient. Higher mean scores are associated with higher levels of satisfaction. |
| Time Frame | The patient satisfaction survey was administered up to two days after surgery. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures |
|---|---|---|---|---|
| Arm/Group Description | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy (PPV) PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with DSEK Descemet Membrane Endothelial Keratoplasty (DMEK) Cataracts with DMEK Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation Endocyclophotocoagulation with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Measure Participants | 85 | 84 | 70 | 44 |
| Mean (Standard Deviation) [score on a scale] |
5.37
(0.57)
|
5.23
(0.72)
|
5.37
(0.68)
|
5.05
(0.87)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cataract Procedures, Retina Procedures, Cornea Procedures, Glaucoma Procedures |
|---|---|---|
| Comments | Testable hypothesis: Patient satisfaction mean will be non-inferior when given oral triazolam in comparison to IV midazolam during all basic cataracts, retina, cornea, and glaucoma ocular procedures. Null hypothesis: The null hypothesis is that the oral sedation group will have a primary endpoint mean equal to or less than that of the IV sedation group by the non-inferiority margin or more. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. A 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative. | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | As a sensitivity analysis, an ANCOVA model will be fit to the data adjusting for factors that are out of balance following randomization. The mean difference between the adjusted means will be calculated. | |
| Method | ANCOVA | |
| Comments | If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV. | |
| Title | Surgeon Satisfaction |
|---|---|
| Description | Surgeon satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per surgeon Higher mean scores are associated with higher levels of satisfaction. |
| Time Frame | The surgeon satisfaction survey will be administered immediately after the completion of the surgery. . |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures |
|---|---|---|---|---|
| Arm/Group Description | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy (PPV) PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with DSEK Descemet Membrane Endothelial Keratoplasty (DMEK) Cataracts with DMEK Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation Endocyclophotocoagulation with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Measure Participants | 85 | 84 | 70 | 44 |
| Mean (Standard Deviation) [score on a scale] |
5.28
(0.97)
|
5.57
(0.84)
|
5.34
(0.95)
|
4.6
(1.37)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cataract Procedures, Retina Procedures, Cornea Procedures, Glaucoma Procedures |
|---|---|---|
| Comments | Null hypothesis: Mean surgeon satisfaction score for oral triazolam will be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures. Alternate hypothesis: Mean surgeon satisfaction score for oral triazolam will not be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative. | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | Surgeon satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals. | |
| Method | ANCOVA | |
| Comments | If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, oral sedation will be deemed non-inferior to IV. | |
| Title | Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction |
|---|---|
| Description | Anesthesiologist/CRNA satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per anesthesiologist/CRNA. Higher mean scores are associated with higher levels of satisfaction. |
| Time Frame | The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures |
|---|---|---|---|---|
| Arm/Group Description | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy (PPV) PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with DSEK Descemet Membrane Endothelial Keratoplasty (DMEK) Cataracts with DMEK Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation Endocyclophotocoagulation with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Measure Participants | 85 | 84 | 70 | 44 |
| Mean (Standard Deviation) [score on a scale] |
5.16
(0.96)
|
5.14
(0.94)
|
5.33
(0.81)
|
4.9
(0.96)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cataract Procedures, Retina Procedures, Cornea Procedures, Glaucoma Procedures |
|---|---|---|
| Comments | Null hypothesis: Mean anesthesiologist/CRNA satisfaction score for oral triazolam will be statistically significant in comparison to mean anesthesiologist/CRNA satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures. Alternate hypothesis:Mean anesthesiologist/CRNA satisfaction score for oral triazolam will not be statistically significant in comparison to mean satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative. | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | Anesthesiologist/CRNA satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals. | |
| Method | ANCOVA | |
| Comments | If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV. | |
| Title | Number of Participants Requiring Additional Anesthesia Intervention |
|---|---|
| Description | The number of subjects in each arm that received additional anesthetic agents during the operative procedure after the initial sedation. |
| Time Frame | Information regarding additional anesthesia intervention will be collected within 2 days of completion of the subjects surgical procedure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures |
|---|---|---|---|---|
| Arm/Group Description | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy (PPV) PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with DSEK Descemet Membrane Endothelial Keratoplasty (DMEK) Cataracts with DMEK Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation Endocyclophotocoagulation with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Measure Participants | 85 | 84 | 70 | 44 |
| Count of Participants [Participants] |
11
12.9%
|
8
9.5%
|
11
15.7%
|
16
36.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cataract Procedures, Retina Procedures, Cornea Procedures, Glaucoma Procedures |
|---|---|---|
| Comments | Null hypothesis:The total additional anesthesia interventions for oral triazolam will be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures. Alternate hypothesis:The total additional anesthesia interventions for oral triazolam will not be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures | |
| Type of Statistical Test | Other | |
| Comments | Additional anesthesia intervention will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals. | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Surgical Complication Rates |
|---|---|
| Description | The number of subjects in each arm that experienced a complication during the operative procedure after the initial sedation. |
| Time Frame | Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not available for one participant in the cornea arm. |
| Arm/Group Title | Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures |
|---|---|---|---|---|
| Arm/Group Description | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy (PPV) PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with DSEK Descemet Membrane Endothelial Keratoplasty (DMEK) Cataracts with DMEK Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation Endocyclophotocoagulation with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Measure Participants | 85 | 84 | 69 | 44 |
| Count of Participants [Participants] |
11
12.9%
|
8
9.5%
|
1
1.4%
|
6
13.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cataract Procedures, Retina Procedures, Cornea Procedures, Glaucoma Procedures |
|---|---|---|
| Comments | Null hypothesis: The total surgical complications for oral triazolam will be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures. Alternate hypothesis: The total surgical complications for oral triazolam will not be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures. | |
| Type of Statistical Test | Other | |
| Comments | Surgical complications will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals. | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same definition of adverse events and serious adverse events as clinicaltrials.gov. With the exception of hypertension, all other adverse events were not related to a particular organ system and occurred as a result of the surgical procedure. | |||||||
| Arm/Group Title | Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures | ||||
| Arm/Group Description | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Pars plana vitrectomy (PPV) PPV with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Descemet Stripping Endothelial Keratoplasty (DSEK) Cataracts with DSEK Descemet Membrane Endothelial Keratoplasty (DMEK) Cataracts with DMEK Conjunctival and/or corneal lesion excisions Pterygium Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | The following ocular procedures will fall under this arm of the study: Ahmed valve Ahmed valve with cataracts Trabeculectomy Trabeculectomy with cataracts Baerveldt Baerveldt with cataracts Endocyclophotocoagulation Endocyclophotocoagulation with cataracts Istent Cataracts with istent Kahook Cataracts with kahook Cypass Cypass with cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study: Triazolam oral sedation with sodium chloride 0.9% intravenous placebo Microcrystalline cellulose oral placebo with midazolam intravenous sedation | ||||
All Cause Mortality |
||||||||
| Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/85 (0%) | 0/84 (0%) | 0/70 (0%) | 0/44 (0%) | ||||
Serious Adverse Events |
||||||||
| Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/85 (1.2%) | 0/84 (0%) | 0/70 (0%) | 0/44 (0%) | ||||
| Surgical and medical procedures | ||||||||
| In-patient Hospitalization | 1/85 (1.2%) | 1 | 0/84 (0%) | 0 | 0/70 (0%) | 0 | 0/44 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Cataract Procedures | Retina Procedures | Cornea Procedures | Glaucoma Procedures | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/85 (9.4%) | 17/84 (20.2%) | 6/70 (8.6%) | 6/44 (13.6%) | ||||
| Surgical and medical procedures | ||||||||
| Pain During Surgery | 1/85 (1.2%) | 1 | 15/84 (17.9%) | 15 | 5/70 (7.1%) | 5 | 3/44 (6.8%) | 3 |
| Nausea & Vomiting Post-surgery | 2/85 (2.4%) | 2 | 7/84 (8.3%) | 7 | 1/70 (1.4%) | 1 | 1/44 (2.3%) | 1 |
| Headache & Dizziness | 3/85 (3.5%) | 3 | 2/84 (2.4%) | 2 | 3/70 (4.3%) | 3 | 2/44 (4.5%) | 2 |
| Anxiety | 1/85 (1.2%) | 1 | 0/84 (0%) | 0 | 0/70 (0%) | 0 | 0/44 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertension | 1/85 (1.2%) | 1 | 0/84 (0%) | 0 | 0/70 (0%) | 0 | 0/44 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Marissa Fiorello, Clinical Research Manager |
|---|---|
| Organization | Boston Medical Center |
| Phone | 617-414-8848 |
| Marissa.Fiorello@bmc.org |
Responsible Party:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT03246724
Other Study ID Numbers:
- H-36590
First Posted:
Aug 11, 2017
Last Update Posted:
Aug 19, 2020
Last Verified:
Aug 1, 2020