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临床试验/NCT02874768
NCT02874768已完成4 期

Comparison Between Dexmedetomidine and Propofol for Postoperative Sedation of Patients in the Intensive Care Unit After Abdominal Surgery: Microcirculation, Kidney Injury, and Intestinal Injury

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Total perfused small vessel density

研究概览

简要总结

This is a single-blind randomized clinical trial. Patients undergoing abdominal surgery will be enrolled and randomly divided into two groups: dexmedetomidine group and propofol group. In the dexmedetomidine group, patients will receive continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h). In the propofol group, patients will receive continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h). Hemodynamics will be continuously monitored using a non-invasive monitoring with chest bioreactance technique at preset time points (0, 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results and fluid balance will be recorded. The microcirculation will be examined by Cytocam. The following microcirculatory parameters will be investigated: total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The enzyme-linked immunosorbent assays will be used to measure serum level of endocan, diamine oxidase, and neutrophil gelatinase-associated lipocalin at preset time points. The primary goal of this study is to compare the effect on microcirculation between dexmedetomidine and propofol in intensive care unit patients after abdominal surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-emergent major abdominal surgery with ICU admission
  • the need of sedation during ICU stay

排除标准

  • age younger than 20 years and older than 89 years
  • refractory bradycardia (HR < 60 bpm after treatment)
  • severe AV block (2nd or 3rd degree)
  • refractory shock (MAP < 60 mm Hg after treatment)
  • severe heart failure or NYHA 4
  • new onset of myocardial infarction within 4 weeks
  • receive CPR within 4 weeks
  • APACHE score > 30 before enrollment
  • severe liver cirrhosis or CHILD B or C
  • pregnancy
  • allergic history to dexmedetomidine or propofol
  • be enrolled in other clinical trials related to dexmedetomidine or propofol within 4 weeks
  • non-native speakers

研究组 & 干预措施

dexmedetomidine

Experimental

Patient receives continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h)

干预措施: Dexmedetomidine (Drug)

Propofol

Active Comparator

Patient receives continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h)

干预措施: Propofol (Drug)

结局指标

主要结局

Total perfused small vessel density

时间窗: 6 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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