Effect of Midazolam as Premedication in Patients Undergoing Breast Conservation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Comparison of frequency of patient satisfaction & anxiety
研究概览
简要总结
Patient are randomized into 2 groups under computer registered numbers. Patient anxiety score is calculated through APAIS SCORE. Then one group is given Midazolam, and the other group is given normal saline and then after one day patients satisfaction is calculated through Lppsq scale.
详细描述
Patient are randomized into 2 groups under computer registered numbers. After taking approval from hospital ethical committee, 124 females fulfilling inclusion criteria are selected. All patients will receive written information about the study on the day before surgery and before signing informed consent. Patient anxiety score is calculated through APAIS SCORE. Then one group is given Midazolam, and the other group is given normal saline and then after one day patients satisfaction is calculated through Lppsq scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing breast conservation surgery
排除标准
- •Patients already on anxiolytic medication
- •Allergy to Midazolam,
- •Patient with diagnosed psychosis,
- •Chronic kidney disease.
研究组 & 干预措施
1 group will be given Midazolam
2nd group will be given normal saline
干预措施: To measure anxiolysis, satisfaction level of patient after receiving Midazolam (Drug)
结局指标
主要结局
Comparison of frequency of patient satisfaction & anxiety
时间窗: 1 day
It is a single blinded randomized control trial 124 adult females scheduled for surgery, were randomized to receive either Intravenous Midazolam or single Placebo before anesthesia induction. Pre and post medication anxiety levels on day of surgery will be assessed on APAIS score. Post operative satisfaction will be assessed on first post operative day using Lppsq.
次要结局
未报告次要终点