Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in blood flow in hepatic artery and main portal vein
研究概览
简要总结
Blood loss in hepatobiliary surgery is correlated with an increase in postoperative complications (e.g. transfusion related lung injury and tumor recurrence) and reduced longterm survival. To reduce morbidity and mortality in hepatobiliary surgery, modulation of the hepato-splanchnic blood flow and pressure is used. In liver surgery pharmacological modulations are widely used to prevent blood loss. For pharmacological modulation central venous pressure is commonly used to reduce the pressure in the inferior vena cava, however little is known about pharmacological effect on blood flow in the hepatic artery and portal vein. The modulation of the hepato-splanchnic blood flow can also play an important role, not only for prevention of blood loss but also for survival of the organs (e.g. ischemic injury due to low flow).
Volatile anesthetics induce a dose-dependent reduction of the hepato-splanchninc blood flow. Propofol however, increases hepatic blood flow when compared with volatile anesthetics. Pharmacological modulation of hepato-splanchnic bloodflow with anesthetics such as sevoflurane or propofol can play an important role in modulation of ischemia/reperfusion injury and survival of organs.
The aim of the study is to determine and to compare the effect of sevoflurane versus propofol on hepatosplanchnic pressure and hepato-splanchnic blood flow during hepatobiliary surgery.
详细描述
All patients receive standardized anesthesia care for hepato-biliary surgery according to the existing anesthesia protocol. The type of anaesthesia will be randomized : propolipid (TIV) or sevorane(inhalation).
At designated times, hemodynamic variables will be recorded.
These will include:
- HF (/min)
- CVP (mmHg),
- MAP (mmHg)
- CI (L/min.m2)
- PPV (pulse pressure variation). Hemodynamic measurement will be done using PiCCO catheter.
The hemodynamic measurements will be compared and related to hepato-splanchnic blood flow and pressure measurements performed by the surgeon:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 years (Female or Male)
- •ASA I - II - III
- •Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
- •Scheduled for hepato-biliary surgery.
排除标准
- •Allergy for the medication
- •Renal insufficiency (SCr > 2 mg/dl)
- •Severe heart failure (EF < 25%)
- •Hemodynamic instable patients
- •Arterial fibrillation
- •BMI > 40
- •Severe coagulopathy (INR > 2)
- •Thrombocytopenia (< 80 x 10³ /µL)
- •History of severe postoperative nausea & vomiting
研究组 & 干预措施
Group P
Group P : Propolipid 1% dose : variable to keep BIS between 40 and 60
干预措施: Propofol Fresenius (Drug)
Group S
Group S : Sevoflurane dose : variable to keep BIS between 40 and 60
干预措施: sevorane (Drug)
结局指标
主要结局
Change in blood flow in hepatic artery and main portal vein
时间窗: From randomization until the end of the whipple surgery
flow/pressure measurements with echo probe and needle
次要结局
- need of inotropic and/or vasopressor support(From start anesthesia until end of anesthesia)
- amount of colloids given during surgery(From start of surgery until end of surgery)
- amount of blood loss(From start of surgery until end of surgery)