Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation:a Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Incidence of hospital-acquired infections
研究概览
简要总结
To compare the incidence of hospital-acquired infections between butorphanol and fentanyl.
详细描述
Butorphanol can improve inflammation and promote the recovery of pro-inflammatory/anti-inflammatory cytokine balance.However, there is still a lack of relevant clinical studies on butorphanol and fentanyl for the incidence of hospital-acquired infections in ICU mechanically ventilated patients.The objective of this study was to evaluate the analgesic efficacy,safety and the incidence of nosocomial infection of butorphanol in mechanical ventilation patients between butorphanol and 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
- 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
- •need mechanical ventilation for more than 48 hours
- •more than 18 years old
- •without hospital-acquired infection before admission to ICU
- •volunteer to participate in this study
排除标准
- •allergic or contraindicated to the drug
- •severe cardiac insufficiency, conduction block and bradycardia
- •recent use of analgesic, sedative and antidepressant drugs
- •psychiatric or neurological diseases or neurosurgery-related diseases
- •history of steroid cortisol and immunosuppressants
- •severe liver dysfunction or renal dysfunction
- •pregnancy
- •refuse to enrollment
研究组 & 干预措施
Butorphanol tartrate
Butorphanol tartrate on the patients with mechanical ventilation
干预措施: Butorphanol Tartrate Injection (Drug)
fentanyl
fentanyl on the patients with mechanical ventilation
干预措施: Fentanyl (Drug)
结局指标
主要结局
Incidence of hospital-acquired infections
时间窗: one month
Incidence of hospital-acquired infections
次要结局
- ICU stay(one month)
- Blood routine examination is assessed by the white blood cell count(on the 1st, 3rd，7th day after enrollment)
- Hospital stay(one month)
- Cytokines(on the 1st, 3rd，7th day after enrollment)
- duration on ventilators(one month)
- all cause mortality(one month)
- Blood routine examination is assessed by neutrophil count.(on the 1st, 3rd，7th day after enrollment)
- adverse events(one month)