Comparative Analysis of Oral Sedation Versus Standard Intravenous Sedation in Vitreoretinal Surgery With Topical Anesthesia and Sub-tenon's Block
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 主要终点
- Patient satisfaction: scale
研究概览
简要总结
The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.
详细描述
After being informed about the study and potential risks, and providing written informed consent, a total of 40 patients will undergo vitreoretinal surgery with oral Triazolam and 40 patients will undergo vitreoretinal surgery with intravenous sedation. The IV sedative will be determined by the anesthesiologist or certified registered nurse anesthetist but limited to midazolam, propofol, and fentanyl. The study will be a prospective, cross-sectional study with a 1:1 randomized procedure and unmasked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing vitreoretinal surgery for a variety of indications including, but not limited to, epiretinal membrane (ERM), macular hole, vitreous opacities, vitreous hemorrhage, aphakia, dislocated or displaced intraocular or crystalline lens, silicone removal, endolaser, and retinal detachment.
- •American Society of Anesthesiologists rating of I-III
排除标准
- •Undergoing vitreoretinal surgery requiring general anesthesia
- •Allergy or hypersensitivity to benzodiazepines
- •Pregnant or nursing females
- •Previous delirium after anesthesia
- •Current use of drug or alcohol on the day of surgery
- •Currently on medications inhibiting cytochrome P450
- •Failed anesthesia clearance
- •Reported anxiety or a history of anxiolytic use
- •Vitreoretinal surgery performed within the last 3 months of the current procedure
- •Impaired renal or liver function
研究组 & 干预措施
Oral Sedative
Participants will receive oral triazolam 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
Followed by topical proparacaine and 6 cc sub-tenon's mixture of lidocaine and marcaine.
Vitals will monitored by the operating room nurses.
干预措施: Oral Sedatives with or Without Analgesia (Drug)
Intravenous Sedative
This group will receive an intravenous sedative. The sedative is limited to midazolam, fentanyl, propofol.
Follow by topical proparacaine and 6 cc sub-tenon's mixture of lidocaine and marcaine.
IV and monitoring will be performed by anesthesiologist or CRNA.
干预措施: Intravenous Sedatives with or Without Analgesia (Drug)
结局指标
主要结局
Patient satisfaction: scale
时间窗: A patient satisfaction survey will be completed at the one-day post operative appointment.
The patient will complete a survey at the one-day post-operative appointment. The survey consists of statements regarding the surgical procedure and experience with a scale of 1 to 6 demonstrating the patient's agreement or disagreement with the statement. Additional questions regarding the surgery and not using the 1 to 6 model will also be asked in the same survey. There will be 14 questions in the 1-6 scale portion of the survey and 4 additional questions. After all questions have been answered, the scaled questions will be analyzed for an average score out of 6 per patient. Additional questions will be analyzed by percentage of each answer. The scaled questions will be used to determine the non-inferiority of the experimental treatment. Additional questions will not be included in the non-inferiority analysis but results will be included in the study.
次要结局
- Surgeon satisfaction: survey(The survey will be completed 10-15 minutes following the completion of the surgery.)
研究者
Erica Podesto
OMS-II
Rocky Vista University, LLC