The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum in the Patients Undergoing Laparoscopic Gastrectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Changes from baseline in heart rate (bpm) after CO2 insufflation
研究概览
简要总结
Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.
详细描述
According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine, the investigators use biased coin design up-and-down method.
Based on the practices, the starting concentration is 0.375 %, and the step size of concentration is 0.125%.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing laparoscopic gastrectomy that require pneumoperitoneum
- •patients who has epidural catheter to manage postoperative pain control
- •patients who agree to our study
排除标准
- •patients who don't agree to our study
- •BMI<16.0 or BMI>35
- •cardiovascular disease, pulmonary disease, renal disease
- •alcoholic abuser or drug abuser
- •any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction
研究组 & 干预措施
laparoscopic gastrectomy with pneumoperitoneum
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Changes from baseline in heart rate (bpm) after CO2 insufflation
时间窗: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
Heart rate will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of heart rate before anesthesia induction will be regarded as the baseline values. If maximum heart rate after Co2 insufflation increased by \>20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
Changes from baseline in mean arterial pressure (mmHg) after CO2
时间窗: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
Mean arterial pressure will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of mean arterial pressure before anesthesia induction will be regarded as the baseline values. If maximum mean arterial pressure after Co2 insufflation increased by \>20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
次要结局
未报告次要终点
研究者
Jiwon Lee
assistant professor
Keimyung University Dongsan Medical Center