Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The total time within target sedation level
研究概览
简要总结
It is well known that ICU patients need sedation. Now no ideal sedation drug existed and every sedation drug has its advantage and disadvantage,so combined sedation may use the advantage and avoid the disadvantage of the sedation drug according to the patients'condition. Until now, there is rare study about the combined sedation or sequenced sedation of different sedation drug.The purpose of the study is to explore the value of combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU, so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the appropriate sedation not under sedation or over sedation,reduce the incidence of delirium, reduce the adverse event of sedation.
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
- None
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
- •ICU patients needing sedation
- •18 years or older
- •mechanically ventilated for less than 96 hours prior to start of study drug.
排除标准
- •Trauma and burn patients as admitting diagnosis.
- •Dialysis of all types.
- •Pregnant or lactation.
- •Neuromuscular blockade other than for intubation.
- •Epidural or spinal analgesia.
- •General anesthesia prior to or planned after the start of study drug infusion
- •Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia).
- •Acute hepatitis or severe liver disease (Child-Pugh class C).
- •Unstable angina or acute myocardial infarction.
- •Left ventricular ejection fraction less than 30%,heart rate less than 50/min. 11.Second or third degree heart block.
- •12.Allergy to the study drug. 13.Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.
- •Patients with renal insufficiency were randomized and treated; however, patients were discontinued if they required dialysis.
研究组 & 干预措施
midazolam
Initiative dosage of midazolam is 0.05 mg/kg given intravenously, the maintenance dosage is 0.01-0.05 mg/kg/h, drug dosage is adjusted by target sedation level.
干预措施: midazolam (Drug)
midazolam
Initiative dosage of midazolam is 0.05 mg/kg given intravenously, the maintenance dosage is 0.01-0.05 mg/kg/h, drug dosage is adjusted by target sedation level.
干预措施: Fentanyl (Drug)
Dexmedetomidine
The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min, the maintenance dosage is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min, the maintenance dosage is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.
干预措施: Fentanyl (Drug)
midazolam & dexmedetomidine
Initiative dosage of midazolam is 0.05 mg/kg given intravenously, The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min(given or not according to patients' condition),.
The maintenance dosage of midazolam is 0.01-0.05 mg/kg/h, the maintenance dosage of dexmedetomidine is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.
干预措施: midazolam (Drug)
midazolam & dexmedetomidine
Initiative dosage of midazolam is 0.05 mg/kg given intravenously, The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min(given or not according to patients' condition),.
The maintenance dosage of midazolam is 0.01-0.05 mg/kg/h, the maintenance dosage of dexmedetomidine is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.
干预措施: Dexmedetomidine (Drug)
midazolam & dexmedetomidine
Initiative dosage of midazolam is 0.05 mg/kg given intravenously, The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min(given or not according to patients' condition),.
The maintenance dosage of midazolam is 0.01-0.05 mg/kg/h, the maintenance dosage of dexmedetomidine is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.
干预措施: Fentanyl (Drug)
结局指标
主要结局
The total time within target sedation level
时间窗: From sedation drug is used to weaning from sedation up to 28 days.
1. Sedation level with RASS score is recorded every 4 hours during sedation. 2. When target sedation was not obtained, sedation drug dosage changed and when adverse event needed to be treated, the sedation level is also recorded. 3. The adjustment of sedation drug is recorded.
次要结局
- The dosage of sedation/analgesic drug(From sedation/analgesic drug is used to weaning from sedation/analgesic up to 28 days.)
- Duration of mechanical ventilation(From beginning to weaning from ventilation up to 28 days..)
- Economic outcome(From admitted to ICU until ventilation and sedation stopped and participants discharged from ICU up to 28 days.)
- Satisfactory of patients to ICU stay from admitted until discharged from ICU(Assessed at time of 1 week participants discharged from ICU.)
- Vital signs(From sedation drug is used to weaning from sedation, up to 28 days.)
- Duration of ICU stay(From date of admission until participants discharged from ICU up to 28 days.)
- Delirium(From sedation drug is used to weaning from sedation, up to 28 days.)
研究者
Qian Zhai
Intensive Care Unit
Qilu Hospital of Shandong University