A Single-center, Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing Oral Sedation to Intravenous Sedation for Ocular Procedures.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Triazolam (Drug)
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
干预措施: Midazolam (Drug)
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
干预措施: Microcrystalline Cellulose (Drug)
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
干预措施: Sodium chloride 0.9% (Drug)
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
干预措施: Triazolam (Drug)
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
干预措施: Midazolam (Drug)
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
干预措施: Microcrystalline Cellulose (Drug)
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
干预措施: Sodium chloride 0.9% (Drug)
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
干预措施: Triazolam (Drug)
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
干预措施: Midazolam (Drug)
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
干预措施: Microcrystalline Cellulose (Drug)
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
干预措施: Sodium chloride 0.9% (Drug)
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
干预措施: Triazolam (Drug)
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
干预措施: Midazolam (Drug)
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
干预措施: Microcrystalline Cellulose (Drug)
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
干预措施: Sodium chloride 0.9% (Drug)
结局指标
主要结局
Patient Satisfaction
时间窗: 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.
次要结局
- Surgeon Satisfaction(The surgeon satisfaction survey will be administered immediately after the completion of the surgery. .)
- Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction(The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case.)