A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Proportion of Days With Delirium
研究概览
简要总结
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.
详细描述
Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>18 years old
- •mechanically ventilated through endotracheal tube
- •anticipated need for ventilation > 48 hours
- •requiring sedative/analgesic medication
排除标准
- •on mechanical ventilator > 96 hours
- •primary neurologic disease
- •post cardiac arrest
- •do not speak English (assessment only English language validated)
- •pregnancy or lactation
- •active myocardial ischemia
- •second or third degree heart block
- •pancreatitis
- •elevated serum triglycerides (> 400 mg/dL)
研究组 & 干预措施
Dexmedetomidine
Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
干预措施: Fentanyl (Drug)
Dexmedetomidine
Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
干预措施: Midazolam (Drug)
Dexmedetomidine
Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
干预措施: Physical and Occupational Therapy (Behavioral)
Propofol
Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
干预措施: Propofol (Drug)
Propofol
Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
干预措施: Fentanyl (Drug)
Propofol
Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
干预措施: Midazolam (Drug)
Propofol
Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
干预措施: Physical and Occupational Therapy (Behavioral)
结局指标
主要结局
Proportion of Days With Delirium
时间窗: daily up to 28 days
delirium assessment using CAM-ICU
次要结局
- Number of Adverse Medication Effects(duration of infusion of study medication up to 28 days)
- Mortality(28 days from enrollment)
- Number of Participants With ICU Complications(daily through day 28)
- Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score(Daily up to day 28)
- Number of Patients Completing Mobility Milestones(Daily through day 28)
- Days on Ventilator(60 days from enrollment)
- Days in ICU(60 days from enollment)
- Number of Patients Requiring Fentanyl(during infusion of study medication up to day 28)
- Days in Hospital(60 days from enrollment)
- Number of Patients Requiring Midazolam(during infusion of study medication through day 28)
- Number of Patients Completing Activities of Daily Living(daily through day 28)