Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- perioperative changes of blood pressure
研究概览
简要总结
Fentanyl is analgesia medication. There has not pain nerve in the lung. Flexible bronchoscopy(FB) is used in the respiratory medicine. So people will not feel pain in the process of FB. The purpose of the study is to know if Fentanyl is useful in the conscious sedation of FB.
详细描述
Fentanyl is opioid receptor agonists. It is a fast-acting, short duration and potent analgesics.
Flexible bronchoscopy (FB) is mostly used in the diagnosis and therapy in the respiratory disease. As we know, there has not pain nerve in the lung. People will not feel pain when they are in FB.
If fentanyl will be effective in FB? Our study will observe the effect of conscious sedation in FB with fentanyl or without fentanyl.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy
排除标准
- •Forced expiratory volume in one second<1 L severe hemoptysis severe heart, liver,kidney failure psychiatric and nervous disorders allergic to the anesthetic ( fentanyl, midazolam, or propofol)
研究组 & 干预措施
FB with fentanyl
In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
干预措施: Fentanyl (Drug)
FB with fentanyl
In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
干预措施: Midazolam (Drug)
FB with fentanyl
In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
干预措施: Propofol (Drug)
FB with fentanyl
In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
干预措施: Bispectral Index monitoring (Device)
FB without fentanyl
In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB
干预措施: Midazolam (Drug)
FB without fentanyl
In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB
干预措施: Propofol (Drug)
FB without fentanyl
In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB
干预措施: Bispectral Index monitoring (Device)
结局指标
主要结局
perioperative changes of blood pressure
时间窗: every 5 minutes from the operation beginning to end
For each patient,bispectral index monitoring after anesthesia. Bp will be measured.
次要结局
- perioperative time(from the operation beginning to end)
- Adverse events(in the process of the operation)
- Patient satisfaction rate(One day after the operation)