Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement
Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic
研究概览
详细说明
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.
研究类型
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- surgical, medical, or trauma patients requiring sedation for mechanical ventilation
- age 18-80
- Anticipated ventilation time of > 24 hrs
- Reasonable chance of recovery
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1. Low dose dexmedetomidine
Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl & propofol.
|
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
其他名称:
|
实验性的:2. High dose dexmedetomidine
Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl & propofol.
|
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
其他名称:
|
安慰剂比较:3. Placebo
Placebo added to fentanyl & propofol.
|
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Total daily dose of fentanyl and propofol
大体时间:Daily
|
Daily
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Total ventilation time
大体时间:Study ended
|
Study ended
|
ICU length of stay
大体时间:Study ended.
|
Study ended.
|
Hospital length of stay
大体时间:Study ended
|
Study ended
|
Patient outcomes/mortality
大体时间:Study ended.
|
Study ended.
|
Total pharmacy expenditures
大体时间:Study ended.
|
Study ended.
|
合作者和调查者
调查人员
- 首席研究员:John A Kappes, Pharm.D.、Avera McKennan Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.