Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- hemodynamic changes depends on the concentration of ropivacaine
研究概览
简要总结
In this trial, the investigators intend to examine whether the concentration of local anesthetics during epidural analgesia could be modulating factor for change of hemodynamics in patients undergoing major upper abdominal surgery.
详细描述
One hundred and twenty patients scheduled for major abdominal surgery under TEA combined general anesthesia were randomized in a double-blinded method to receive one of three different concentration study solutions in 8 ml of volume after the induction of anesthesia: 0.75% ropivacaine (60 mg), 0.375% ropivacaine (30 mg), or 0.2% ropivacane (16 mg).
In each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. The acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all of the followings needed.
- •ASA I or II patients
- •18 to 65 years old
- •undergoing major upper abdominal surgery
- •planned combined thoracic epidural analgesia and general anesthesia
排除标准
- •any contraindication to epidural analgesia
- •allergy to local anesthetics of the amide type
- •communication difficulties that would prevent reliable assessment
- •known significant cardiac or respiratory disease
- •patients who were not in cardiac sinus rhythm
研究组 & 干预措施
0.75% ropivacaine
0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
干预措施: 0.75% ropivacaine concentration (Drug)
0.2% ropivacaine
0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia
干预措施: 0.2% ropivacaine concentration (Drug)
0.375% ropivacaine
0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
干预措施: 0.375% ropivacaine concentration (Drug)
结局指标
主要结局
hemodynamic changes depends on the concentration of ropivacaine
时间窗: during 1hour after administration of epidural drug dosing
Systolic blood pressure, diastolic blood pressure, MAP, HR, stroke volume, stroke volume, stroke volume index, stroke volume variation, cardiac output, and cardiac index were continuously measured at 5 minute intervals during 1 hour.
次要结局
- Age based hemodynamic changes depends on the concentration of ropivacaine(during 1hour after administration of epidural drug dosing)
研究者
Hyeon-Jeong Lee
Assisstant Professor
Pusan National University Hospital