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临床试验/NCT01144546
NCT01144546已完成2 期

Passive Leg Raising Test to Predict Hypotension During Induction of Anesthesia in Patients Undergoing Cardiac Surgery

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
42
试验地点
1
主要终点
The area under ROC curve to predict hypotension and refractory hypotension

研究概览

简要总结

Hypotension frequently occurs during anesthesia induction. Preload decrease by anesthetics was often considered as one of main causes for this hypotension. However, the studies on this topic have been lacking. Dynamic preload indices are more suitable than static preload indices to predict the effect of preload changes. And, recently, passive leg raising test showed successful results to predict fluid responsiveness in patient with spontaneous ventilation.

The investigators hypothesized that hypotension after induction of anesthesia is caused by decrease of preload by anesthetics and passive leg raising test could predict this hypotension. In this study, the investigators will try to evaluate whether passive leg raising induced hemodynamic changes could predict hypotension during anesthesia induction.

详细描述

In this randomized controlled clinical trial, the investigators hypothesized that passive leg raising induced changes in hemodynamic parameters could predict the hypotension during anesthesia induction. To evaluate this, before anesthesia, the investigators will conduct passive leg raising test. At first, the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak CO (usually within 1-2 min). Hemodynamic profiles planned to be measured are mean arterial pressure, heart rate, cardiac index, stoke volume and stroke volume variation. After this, the occurrence of hypotension (systolic blood pressure < 90mmHg or mean arterial pressure decrease > 30% of baseline) will be recorded during the time from anesthesia induction to surgical skin incision. Hypotension will be treated by a standardized method. If heart rate (HR) is less than 70 beats/min, 5mg of ephedrine will be administered and if HR is greater than 70 beats/min, 30 mcg of phenylephrine will be administered. This will repeated until hypotension subsided. Refractory hypotension will be defined as continuous hypotension despite the total infused dose of ephedrine > 0.5 mg/kg or phenylephrine > 4 mcg/kg. The ability to predict hypotension and refractory hypotension during anesthesia induction by passive leg raising test will be evaluated by receiver operating characteristic curve analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients undergoing elective cardiac surgery

排除标准

  • arrhythmias
  • documented peripheral artery disease
  • severe pulmonary disease
  • heart failure
  • unstable angina
  • preoperative use of inotropics or mechanical assist device
  • use of angiotensin converting enzyme inhibitors
  • expected intubation difficulty or gastric reflux disease

结局指标

主要结局

The area under ROC curve to predict hypotension and refractory hypotension

时间窗: 30 min around passive leg raising test

area under ROC curve of HR, SV, SVV, and CI changes during PLR to predict hypotension and refractory hypotension

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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