Goal Directed Fluid Therapy Based on Pulse Pressure Variation Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- episode of intraoperative hypotension
研究概览
简要总结
The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery
- •thoracic/lumbar spine surgery >= 3 levels and duration >= 3 hours
排除标准
- •Cr >2 mg/dl or eGFR < 60 ml/min
- •coronary artery disease, congestive heart failure or cardiac arrhythmia
- •BMI >30 kg/m2
- •hemodynamic unstable, preoperatively
- •uncontrolled hypertension
- •respiratory system compliance < 30 ml/cmH2O
研究组 & 干预措施
GDFT group
The GDFT group will receive 400 ml of 12.5% carbohydrate drink after 6 pm until the bed time in the day before surgery and 200 ml in the morning of the surgery day. Acetate ringer solution will be start at 7:00. After induction PPV will be measure and fluid bolus 200 ml in 10 minutes will be given if PPV >13 before prone position. During the operation, the patient in GDFT group will receipt fluid therapy according to acceptable PPV
干预措施: goal directed fluid therapy (Procedure)
controlled group
The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order.
干预措施: Controlled (Other)
结局指标
主要结局
episode of intraoperative hypotension
时间窗: intraoperative
Blood pressure will be record continuously using arterial catheter in both group. Number of participants and episode of hypotension (defined as SBP \< 90 mmHg or MAP \< 60 mmHg or decrease of SPB \>= 25% from baseline for 5 minutes or need vasopressor) therapy
次要结局
- unit of blood transfusion(intraoperative and up to 24 hours postoperatively)