Perioperative Hemodynamic Optimization Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Maximal MAP fluctuation
研究概览
简要总结
Lymphatic venous anastomosis could be applied on patients suffering from limb lymphedema after surgery or radiotherapy. The particular pathophysiology leads unconventional fluid treatment strategy and changes in urine output. Hemodynamic monitors shows the benefits in perianesthetic care in fluid maintenance and decrease postanesthetic complication.
Invasive hemodynamic monitors, such as arterial line and FlowTrac, have risks of hematoma, infection, nerve injury in puncture site. In this study, photoplethysmography is applied comparing with conventional mean arterial pressure for perianesthetic hemodynamic optimization in bispectral index (BIS)-guided target-controlled infusion sedation on lymphatic venous anastomosis.
详细描述
After allocation, patients would be assigned to Standard group or ClearSight group. All patients will be sedative with BIS-guided Propofol/Alfentanil Target-Controlled Infusion. The BIS will be maintained between 40-70 with electromyography(EMG) < 30%. Ce(effect site concentration) of Propofol is adjusted according to BIS score. Ce of Alfentanil is adjusted between 15-75 ng/ml. Patients have spontaneous respiration during the procedure with O2 simple mask. If the oxygen saturation by pulse oximetry(SpO2) < 95%, prescribe chin lift first. Nasopharyngeal airways is given if chin lift can not improve the saturation. Crystalloid, usually Lactate Ringer, is infused with the rate 4ml/kg/hr. The goal of Standard group is to maintain mean arterial pressure(MAP) > 60%. If MAP < 60%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed. ClearSight group is to maintain stroke volume(SV). If SV decreases more than 10%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject receiving lymphatic venous anastomosis operation with Bispectral-guided Propofol and Alfentanil target-controlled anesthesia
- •Subject agrees to participate the study
排除标准
- •Age less than 18 years old
- •Creatinine clearance < 30ml/min
- •Vulnerable populations, including children, pregnant women, inmates, and persons with no capacity or with limited capacity
研究组 & 干预措施
Standard group
Adult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis
干预措施: Standard group (Device)
ClearSight
Adult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis
干预措施: ClearSight (Device)
结局指标
主要结局
Maximal MAP fluctuation
时间窗: after induction until recovery from anesthesia, assessed up to 24 hours
In standard group, MAP(mean arterial pressure measured from arterial line), maximum minus minimum
Maximal change of SVV
时间窗: after induction until recovery from anesthesia, assessed up to 24 hours
In ClearSight group, SVV(stroke volume variation measured from ClearSight), maximum minus minimum
次要结局
- Urine output(after induction until recovery from anesthesia, assessed up to 24 hours)
- Creatinine(preanesthesia and 24 hours postanesthesia)
- Acute kidney injury(Loss of kidney function that develops within 7 days after surgery)
- Total fluid volume (ml)(after induction until recovery from anesthesia, assessed up to 24 hours)