NCT01594021终止4 期
Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Hypotension
研究概览
简要总结
Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.
详细描述
This is a randomized, prospective study which will include a total of 200 patients who are scheduled to undergo elective surgery. The research participants will be randomly assigned to
- a control group that will receive a low preemptive volume loading (50 mL of gelatin),
- a protocol group that will receive a high preemptive volume loading (500 mL of gelatin).
Volume loading is preceded by the measurement of stroke volume and cardiac output before and after a passive leg elevation test and followed by a standardized anesthetic protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Adult patients undergoing elective surgery.
排除标准
- •Difficult peripheral venous access
- •Allergy to gelatin
- •Symptomatic cardiac disease, rhythm trouble, pace-maker, aortic valvular disease, aortic disease
- •Morbid obesity, low BMI,
- •hypovolemia,
- •Raynaud syndrome or scleroderma,
- •Contra-indication to propofol, remifentanil or to the use of Bispectral Index,
- •Hematocrit < 20%.
研究组 & 干预措施
High pre-emptive volume loading
Experimental
干预措施: Gelatin 500 mL (Drug)
Low pre-emptive volume loading
Active Comparator
干预措施: Gelatin 50 mL (Drug)
结局指标
主要结局
Hypotension
时间窗: 30 minutes
mean arterial pressure less than 70% of the baseline measurement
次要结局
- hemodynamic effect of leg passive elevation test(30 minutes)
- hemodynamic effect of volume loading(30 minutes)
- heart rate monitoring(30 minutes)
- propofol dose when bispectral index is 50(30 minutes)
- propofol site effect concentration when bispectral index is 50(30 minutes)
- arterial pressure monitoring(30 minutes)
研究者
研究点 (1)
Loading locations...
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