NCT01121055Unknown4 期
Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- patient satisfaction
研究概览
简要总结
Many patients undergoing flexible bronchoscopy (FB) experience anxiety and discomfort during the procedure. The investigators want to evaluate whether an additional Lorazepam premedication would improve patient satisfaction for FB.
详细描述
The enrolled patients are randomized to either the control or Lorazepam groups according to a random sample chart of numbers. The patients complete questionnaires about baseline anxiety level and satisfaction for FB within 24 hours after the FB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Adult patients (aged 18 years or older) admitted to the Respiratory Department
排除标准
- •outpatient procedures
- •therapeutic bronchoscopy
- •expected operation or discharge within 24 hours after the FB
- •sedative premedication
- •endotracheal intubation with mechanical ventilation
- •inability to speak Korean
研究组 & 干预措施
Control
Placebo Comparator
Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB
干预措施: Control (Drug)
Lorazepam
Experimental
Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
干预措施: Lorazepam (Drug)
结局指标
主要结局
patient satisfaction
时间窗: within 24 hr of bronchoscopy
次要结局
- relationship between patient satisfaction and sleep quality, anxiety level(24hr before and after bronchoscopy)
研究者
研究点 (1)
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