Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Total daily dose of fentanyl and propofol
研究概览
简要总结
Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
详细描述
Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.
Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.
Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.
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
- Triple (Participant, Care Provider, Investigator)
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
- •surgical, medical, or trauma patients requiring sedation for mechanical ventilation
- •age 18-80
- •Anticipated ventilation time of > 24 hrs
- •Reasonable chance of recovery
排除标准
- •Severe COPD
- •Chronic immunosuppression (equivalent to prednisone 7.5 mg daily or higher)
- •Heart block
- •Bradycardia
- •Significant head injury
- •Goal SAS score of 1-2
- •Severe hepatic impairment
- •Hypertriglyceridemia
- •Allergy to dexmedetomidine, fentanyl, propofol or eggs
研究组 & 干预措施
1. Low dose dexmedetomidine
Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl & propofol.
干预措施: Dexmedetomidine (Drug)
2. High dose dexmedetomidine
Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl & propofol.
干预措施: Dexmedetomidine (Drug)
3. Placebo
Placebo added to fentanyl & propofol.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Total daily dose of fentanyl and propofol
时间窗: Daily
次要结局
- Total ventilation time(Study ended)
- ICU length of stay(Study ended.)
- Hospital length of stay(Study ended)
- Patient outcomes/mortality(Study ended.)
- Total pharmacy expenditures(Study ended.)