Trial Outcomes & Findings for Oral Versus Intravenous Sedation for Ocular Procedures (NCT NCT03246724)
NCT ID: NCT03246724
Last Updated: 2020-08-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
327 participants
Primary outcome timeframe
The patient satisfaction survey was administered up to two days after surgery.
Results posted on
2020-08-19
Participant Flow
Patients were recruited from October 26th, 2017 to November 30th, 2019 at the outpatient eye clinic, Ophthalmology Department, Boston Medical Center.
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.
Participant milestones
| Measure |
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
|
Retina Procedures
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
|
Cornea Procedures
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
99
|
91
|
85
|
52
|
|
Overall Study
COMPLETED
|
85
|
84
|
70
|
44
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
15
|
8
|
Reasons for withdrawal
| Measure |
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
|
Retina Procedures
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
|
Cornea Procedures
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
|
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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
4
|
2
|
|
Overall Study
Ineligible on day of surgery
|
7
|
2
|
0
|
3
|
|
Overall Study
Study completed before surgical date
|
2
|
1
|
8
|
1
|
|
Overall Study
Transferred to other arm
|
0
|
0
|
1
|
0
|
|
Overall Study
Unable to obtain medication timely
|
0
|
2
|
2
|
1
|
|
Overall Study
Re-consented to participate
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Oral Versus Intravenous Sedation for Ocular Procedures
Baseline characteristics by cohort
| Measure |
Cataract Procedures
n=85 Participants
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
|
Retina Procedures
n=84 Participants
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
|
Cornea Procedures
n=70 Participants
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
|
Glaucoma Procedures
n=44 Participants
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
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.59 years
STANDARD_DEVIATION 9.14 • n=99 Participants
|
57.02 years
STANDARD_DEVIATION 12.65 • n=107 Participants
|
49.96 years
STANDARD_DEVIATION 14.99 • n=206 Participants
|
66.52 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
59.67 years
STANDARD_DEVIATION 13.96 • n=31 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
124 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
159 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
98 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
176 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
109 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
58 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
112 Participants
n=31 Participants
|
|
Language
English
|
51 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
158 Participants
n=31 Participants
|
|
Language
Spanish
|
26 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
97 Participants
n=31 Participants
|
|
Language
Haitian Creole
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Body Mass Index (BMI)
|
31.12 kg/m^2
STANDARD_DEVIATION 6.44 • n=99 Participants
|
29.86 kg/m^2
STANDARD_DEVIATION 6.1 • n=107 Participants
|
29.91 kg/m^2
STANDARD_DEVIATION 5.48 • n=206 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 5.94 • n=7 Participants
|
29.77 kg/m^2
STANDARD_DEVIATION 5.94 • n=31 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cataract Procedures
n=85 Participants
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
|
Retina Procedures
n=84 Participants
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
|
Cornea Procedures
n=70 Participants
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
|
Glaucoma Procedures
n=44 Participants
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
|
|---|---|---|---|---|
|
Patient Satisfaction
|
5.37 score on a scale
Standard Deviation 0.57
|
5.23 score on a scale
Standard Deviation 0.72
|
5.37 score on a scale
Standard Deviation 0.68
|
5.05 score on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cataract Procedures
n=85 Participants
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
|
Retina Procedures
n=84 Participants
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
|
Cornea Procedures
n=70 Participants
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
|
Glaucoma Procedures
n=44 Participants
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
|
|---|---|---|---|---|
|
Surgeon Satisfaction
|
5.28 score on a scale
Standard Deviation 0.97
|
5.57 score on a scale
Standard Deviation 0.84
|
5.34 score on a scale
Standard Deviation 0.95
|
4.6 score on a scale
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cataract Procedures
n=85 Participants
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
|
Retina Procedures
n=84 Participants
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
|
Cornea Procedures
n=70 Participants
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
|
Glaucoma Procedures
n=44 Participants
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
|
|---|---|---|---|---|
|
Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction
|
5.16 score on a scale
Standard Deviation 0.96
|
5.14 score on a scale
Standard Deviation 0.94
|
5.33 score on a scale
Standard Deviation 0.81
|
4.9 score on a scale
Standard Deviation 0.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Cataract Procedures
n=85 Participants
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
|
Retina Procedures
n=84 Participants
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
|
Cornea Procedures
n=70 Participants
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
|
Glaucoma Procedures
n=44 Participants
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
|
|---|---|---|---|---|
|
Number of Participants Requiring Additional Anesthesia Intervention
|
11 Participants
|
8 Participants
|
11 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure.Population: Data was not available for one participant in the cornea arm.
The number of subjects in each arm that experienced a complication during the operative procedure after the initial sedation.
Outcome measures
| Measure |
Cataract Procedures
n=85 Participants
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
|
Retina Procedures
n=84 Participants
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
|
Cornea Procedures
n=69 Participants
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
|
Glaucoma Procedures
n=44 Participants
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
|
|---|---|---|---|---|
|
Surgical Complication Rates
|
11 Participants
|
8 Participants
|
1 Participants
|
6 Participants
|
Adverse Events
Cataract Procedures
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Retina Procedures
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cornea Procedures
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Glaucoma Procedures
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cataract Procedures
n=85 participants at risk
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
|
Retina Procedures
n=84 participants at risk
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
|
Cornea Procedures
n=70 participants at risk
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
|
Glaucoma Procedures
n=44 participants at risk
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
|
|---|---|---|---|---|
|
Surgical and medical procedures
In-patient Hospitalization
|
1.2%
1/85 • Number of events 1 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/84 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/70 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/44 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
Other adverse events
| Measure |
Cataract Procedures
n=85 participants at risk
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
|
Retina Procedures
n=84 participants at risk
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
|
Cornea Procedures
n=70 participants at risk
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
|
Glaucoma Procedures
n=44 participants at risk
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
|
|---|---|---|---|---|
|
Surgical and medical procedures
Pain During Surgery
|
1.2%
1/85 • Number of events 1 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
17.9%
15/84 • Number of events 15 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
7.1%
5/70 • Number of events 5 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
6.8%
3/44 • Number of events 3 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
|
Surgical and medical procedures
Nausea & Vomiting Post-surgery
|
2.4%
2/85 • Number of events 2 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
8.3%
7/84 • Number of events 7 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
1.4%
1/70 • Number of events 1 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
2.3%
1/44 • Number of events 1 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
|
Surgical and medical procedures
Headache & Dizziness
|
3.5%
3/85 • Number of events 3 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
2.4%
2/84 • Number of events 2 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
4.3%
3/70 • Number of events 3 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
4.5%
2/44 • Number of events 2 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
|
Vascular disorders
Hypertension
|
1.2%
1/85 • Number of events 1 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/84 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/70 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/44 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
|
Surgical and medical procedures
Anxiety
|
1.2%
1/85 • Number of events 1 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/84 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/70 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
0.00%
0/44 • Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
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.
|
Additional Information
Marissa Fiorello, Clinical Research Manager
Boston Medical Center
Phone: 617-414-8848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place