Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Decompression Surgery in the Prone Position: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Lactic acid concentrations throughout the perioperative
研究概览
简要总结
This is a randomized controlled clinical trial which investigates whether goal directed fluid therapy( GDT ) would show the evidence of benefit from GDT in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.
详细描述
This is a single-center, randomized controlled clinical trial. Patients aged > 60 undergoing lumbar decompression surgery will be randomly assigned to either a GDT ( goal directed fluid therapy) group or a control group, who received conventional anesthesiologist-directed fluid therapy. Perioperative lactic acid concentrations with 7 different time point, intraoperative fluid balance and postoperative complications from admittance to 30 days after surgery were recorded. This RCT is conducted to show the evidence of benefit from GDT in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients were assigned to one of the two groups (control group and GDT group) using a computer-generated randomization scheme.Allocation concealment was obtained using number labeled opaque envelopes that were opened just before the surgery. Data were collected by persons unaware of treatment allocation.
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 60 years, American Society of Anesthesiologists score II-III, and expected duration of operation > 2 h
排除标准
- •Patients with severe cardiac arrhythmia (which would affect the accuracy of stroke volume variation as an indicator of fluid responsiveness), vascular disease (which would prohibit radial artery cannulation), and mental disorder were excluded
研究组 & 干预措施
GDT group
The fluid in GDT group (Goal-directed fluid therapy) will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the LiDCO monitoring system.
干预措施: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO） (Other)
Control group
Patients in the control group received conventional fluid therapy, decided by the attending anesthesiologists based on the patient's hemodynamic condition and responses, to maintain MAP >65 mm Hg, heart rate 50-100 bpm, and urine output >0.5 ml/kg/h.
结局指标
主要结局
Lactic acid concentrations throughout the perioperative
时间窗: from 24 hours before surgery to 24 hours after the surgery
the change of lactic acid concentrations(mmol/l) throughout the perioperative period
次要结局
- intraoperative fluid balance, DO2I and predefined moderate or major postoperative complications in 30-day.(30 days after the surgery)
研究者
Huang YuGuang
Professor，Chairman
Peking Union Medical College Hospital