Oral Versus Intravenous Sedation for Ocular Procedures

Phase 4

Completed

Conditions: Surgery
Sedation

Interventions: Drug: Triazolam
Drug: Midazolam
Drug: Microcrystalline Cellulose
Drug: Sodium chloride 0.9%

Registration Number: NCT03246724

Lead Sponsor: Boston Medical Center

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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 327

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retina Procedures	Midazolam	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
Cornea Procedures	Sodium chloride 0.9%	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
Cataract Procedures	Sodium chloride 0.9%	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	Sodium chloride 0.9%	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
Glaucoma Procedures	Sodium chloride 0.9%	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
Cataract Procedures	Triazolam	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
Cataract Procedures	Midazolam	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
Cataract Procedures	Microcrystalline Cellulose	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	Microcrystalline Cellulose	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
Retina Procedures	Triazolam	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
Cornea Procedures	Midazolam	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
Cornea Procedures	Triazolam	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
Cornea Procedures	Microcrystalline Cellulose	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
Glaucoma Procedures	Midazolam	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
Glaucoma Procedures	Triazolam	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
Glaucoma Procedures	Microcrystalline Cellulose	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.