The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Continuous pumping dose of nalbuphine
研究概览
简要总结
The aim of this study is to determine the effective nalbuphine dose in 90% of intubated patients in the ICU, including the continuous infusion dose and a bolus dose during moving to the lateral decubitus position. Pain will assessed using a Behavioural Pain Scale (BPS) requiring a score of 3-4.
详细描述
The continuous nalbuphine infusion dose starts at 100ug/kg/h, if the BPS scores reaches 3-4, the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. If not, increased by 20 ug/kg/h.
The nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at 0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a BPS score of 3-4 is obtained.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical invasive ventilation
- •Sedated only with nalbuphine
排除标准
- •Pregnant or breast-feeding woman
- •Age below 18 or over 80 years
- •An indication for deep sedation (e.g.the initial stage of septic shock, acute brain injury or acute respiratory distress syndrome)
- •Renal dialysis
- •The inability to assess pain by the BPS scale (e.g. paralysis)
- •BMI less than 18 or more than 35
- •Preadmission use of opioid analgesic for chronic pain
- •Severe hepatic failure
- •State of consciousness with impossibility to use self-assessment scale; monoamine oxidase inhibitors
研究组 & 干预措施
Nalbuphine
干预措施: Nalbuphine (Drug)
结局指标
主要结局
Continuous pumping dose of nalbuphine
时间窗: 2 days
The effective continuous infusion dose of nalbuphine to obtain a satisfactory analgesia
Nalbuphine bolus dose
时间窗: 3 days
The effective dose of a nalbuphine bolus to obtain a satisfactory analgesia
次要结局
未报告次要终点
研究者
Hua-Qing Shu
Associate chief physician
Wuhan Union Hospital, China