A Comparison of Hemodynamic Effects Between Dexmedetomidine and Propofol for Sedation in Patients With Major Abdominal Tumor Surgery
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
- cardiac index
研究概览
简要总结
This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of Propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output and Hemodynamic Monitor at preset time points (time of recruitment [0h], 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid volume and drugs used were also recorded.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-emergent major abdominal tumor surgery with ICU admission
- •the need of sedation during ICU stay
排除标准
- •age older than 99 years
- •age younger than 20 years
- •refractory arrhythmias
- •refractory shock status after resuscitation
- •new onset of myocardial infarction
- •severe heart failure or NYHA 4
- •APACHE score > 30 when recruiting
- •severe liver cirrhosis or CHILD B or C
- •organ transplantation within one year
- •pregnancy
- •allergic to propofol or dexmedetomidine
研究组 & 干预措施
propofol
these patients are sedated with propofol infusion during ICU admission
干预措施: Propofol (Drug)
dexmedetomidine
these patients are sedated with dexmedetomidine infusion during ICU admission
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
cardiac index
时间窗: six hours after recruitment
the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment
次要结局
- heart rate(six hours after recruitment)
- urine output(six hours after recruitment)
- mean arterial pressure(six hours after recruitment)
- stroke volume(six hours after recruitment)