Comparison of Goal-directed and Liberal Fluid Management With Minimal Invasive Hemodynamic Monitoring in Abdominal Surgeries: A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Peroperative Hemodiynamic, Cardiac output
研究概览
简要总结
Background: The investigators aim is to indicate that the "goal directed fluid management" is more effective for open abdominal surgeries by performing perioperative hemodynamic monitorisation using a minimal invasive pulse counter analysis method.
Methods: The study will be included 90 participants with ASA II-III risk score aged from 18-64 years. The prospective and randomized participants will be divided into 2 groups as liberal (Group L) and goal-directed fluid therapy (Group G) fluid treatment. Hemodynamic parameters and arterial blood gas analysis will be recorded at 30 min intervals. Preoperative and postoperative creatinine values, CR-POSSUM physiological score, Charlson comorbidity index (CCI), perioperative and postoperative vasopressor use, postoperative acute kidney injury network (AKIN), postoperative intensive care requirements, duration of hospital stay and 30-day mortality will be recorded.
详细描述
Blood will be taken and assessed from the participants preoperatively one day before surgery and creatinine, neutrophil, lymphocyte and neutrophil / lymphocyte values will be recorded.
Though the gastrointestinal surgery team is the same, randomization will not be applied for the primary operating surgeon and primary surgeon selection will not be performed. Participants in both groups will have age, gender, height, weight, body mass index (BMI), comorbidities, CCI, POSSUM physiologic score and ASA risk score recorded. After being taken to the operation room, standard monitoring (ECG, SO2, NIBP) will be performed. A peripheral venous route will be opened with an 18-gauge needle. Participants will be began 5 mL/kg/hr crystalloid (isolyte) infusion as standard. Later participants who accept will have an epidural catheter inserted at the thoracic 10-11 level. After ensuring hemodynamic stabilization in both groups, sedation will be provided with 0.03 mg/kg midazolam and arterial monitoring will be provided with radial artery cannulation with a 20-gauge peripheral cannula.
Induction and General Anesthesia Management:
For induction 1-2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used, and participants will be orotracheally intubated after two minute ventilation. A MAQUET flow-I anesthesia device will be placed in volume control (VC) mode by setting to 8 mL/kg tidal volume and 12/min respiratory count according to ideal body weight with PetCO2 35-45 mmHg. Later, central venous catheterization will be performed on the right internal jugular vein using USG guidance. Sevoflurane (MAC 0.7-0.9) and remifentanil infusion (0.05-0.3 mcg/kg/min) will be used in anesthesia maintenance.
Monitoring:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with major abdominal surgery
- •ASA risk classification II-III
排除标准
- •Peripheral artery disease
- •Not in sinus rhythm
- •Peroperative major hemorrhage (more than 500 mL hemorrhage within 1 hour)
- •Pregnant or breastfeeding
- •Advanced degree of liver and renal failure
研究组 & 干预措施
Goal-directed fluid treatment
Fluid management will be performed according to SVV and CI monitoring. When patients have SVV>10%, 250 cc crystalloid will be administered and when SVV fell below 10% during 30-minute monitoring standard (5 mL/kg/hr) crystalloid infusion continues. If SVV continues above 10%, a second fluid bolus of 250 cc colloid (minifluid challenge) will be administered.
If the desired SVV level can not be reached, the Hct values will be examined. Blood replacement will be performed when Hct<30% in patients with coronary artery disease (CAD) and when Hct<25% for other patient groups. If the desired SVV level can not be reached in spite of blood replacement products, if CI will be below 2.5 L/min/m2 vasopressor will begun. If SVV will be at normal values with CI below 2.5 L/min/m2, inotrop will begun.
干预措施: Goal-directed fluid treatment (Other)
liberal fluid treatment
Fluid management will be performed according to MAP, HR and urine output.
If peroperative urine amounts will be <0.5 mL/kg/hr during two-hour monitoring, with MAP<65 mmHg, HR>100/min for at least 30 minutes and CVP falls 20% compared to basal values, the same anesthesiologist will begin additional fluid replacement of 5 mL/kg/hr based on clinical experience.
Blood product replacement will be provided at Hct<30% for those with coronary artery disease and at Hct<25% for other patients.
干预措施: Liberal Fluid Therapy (Other)
结局指标
主要结局
Peroperative Hemodiynamic, Cardiac output
时间窗: During the surgery
Cardiac Index (l/min/m2)
Peroperative Hemodiynamic, Mean Arterial Pressure
时间窗: During the surgery
Mean arterial pressure (mmHg)
Peroperative Hemodiynamic, Kidney Function
时间窗: During the surgery
Urine output (ml/h)
Peroperative Hemodiynamic, Pulse
时间窗: During the surgery
Heart rate (beats per minute)
Peroperative Hemodiynamic, Fluid response
时间窗: During the surgery
Stroke Volume Variation (%)
次要结局
- Number of Participants(5 months)