Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Patient Questionnaire (generated by institution)
研究概览
简要总结
Purpose: This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.
详细描述
Purpose: This study compares administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.
Patients and methods: Patients will be randomly assigned to one of two groups: midazolam given via traditional intravenous route or midazolam via a nasal atomizer. Outcomes are patient perception of anxiety with the drug delivery method, discomfort with administration, pain during the procedure, and length of sedation effects. Medical personnel rated ease of use, efficacy, time to sedation and time to transport after procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •all men who request no-scalpel vasectomy procedure
排除标准
- •anyone not eligible for no-scalpel vasectomy procedure
研究组 & 干预措施
midazolam delivery via nasal atomizer
normal sedation given via nasal atomizer
干预措施: intravenous midazolam (Drug)
midazolam delivery via intravenous
normal sedation given via Intravenous route
干预措施: midazolam by nasal atomizer (Device)
结局指标
主要结局
Patient Questionnaire (generated by institution)
时间窗: 1 year
comparison between groups
次要结局
- Nursing Questionnaire (generated by institution)(1 year)