Effect of Low Tidal Volume Ventilation Strategy Combined Goal -Directed Fluid Therapy on Intraoperative Bleeding Undergoing Laparoscopic Major Hepatectomy in Liver Cancer Patients: a Surgeon Blinded Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
This randomized controlled study's objective is to find a safer mechanical ventilation strategy to reduce intraoperative bleeding in liver cancer patients undergoing laparoscopic major liver resection. The hypothesis is that low tidal volume ventilation in laparoscopic major hepatectomy results in less bleeding.
详细描述
Patients are randomized into the conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group and low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume group and ventilated accordingly throughout the surgery. All patients undergo general anesthesia with propofol, remifentanil, and rocuronium and are intubated with an endotracheal tube (ID 7.0 for females, ID 7.5 for males). Anesthesia is maintained with sevoflurane, end tidal CO2 is targeted between 30-35mmHg. The radial artery is cannulated and connected to the Flotrac sensor and goal directed fluid therapy is done. The estimated blood loss is checked as the primary outcome. In addition postoperative complications, transfusion amounts, operation time, satisfaction of the surgeon and participants are 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hepatocellular carcinoma scheduled for laparoscopic major hepatectomy, defined as resection of more than 30% of non-anatomical resection or more than 3 segments
排除标准
- •ASA class >4
- •patients with chronic obstructive pulmonary disease
- •patients with Child-Pugh score C
- •patients with arrythmia
结局指标
主要结局
Intraoperative blood loss
时间窗: during surgery
amount drained from peritoneal cavity - irrigation fluid
次要结局
- Satisfaction scale of the operator and participants(during surgery)
- transfusion amount(op. end ~ postoperative day 3)
- postoperative alanine aminotransferase level(op. end ~ postoperative day 3)
- postoperative lung complications(op end ~ postoperative 2 weeks)
- postoperative hemoglobin level(op. end ~ postoperative day 3)
- postoperative total bilirubin level(op. end ~ postoperative day 3)
- postoperative PT INR level(op. end ~ postoperative day 3)
- operation time(during surgery)
- postoperative aspartate aminotransferase level(op. end ~ postoperative day 3)
- postoperative serum creatinine level(op. end ~ postoperative day 3)
- amount of crystalloids infused(during surgery)