Perioperative Goal Directed Fluid Therapy During Radical Cystectomy: the Impact of Stroke Volume Optimization vs Dynamic Central Venous Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Perioperative hypotension
研究概览
简要总结
Although fluid therapy is of paramount value in anesthetic practice, there is no guideline available for perioperative fluid management in major abdominal surgery. So, there is a need to establish whether goal directed fluid therapy protocol is effective during radical cystectomy and urinary diversion. A balance of perioperative fluid therapy is crucial, yet the method to achieve this equilibrium remains a highly debated subject. Therefore, this study will be designed to investigate the effects of two individualized goal directed fluid therapy during radical cystectomy to encourage an effective circulating blood volume and pressure. Accordingly, as a primary outcome, the investigators assume that stroke volume optimization could maintain better perioperative hemodynamic stability with low incidence and severity of hypotensive episodes together with achievement of maximal oxygenation. Hopefully this regimen could help to decrease the possibility of perioperative tissue hypoperfusion and the possible associated complications as a secondary outcome.
详细描述
Study protocol:
Patients will be randomly assigned to one of two equal groups, according to computer-generated randomization sequence into:
- Stroke volume optimization group (SVO group).
- Central venous pressure dynamic group(CVPdyngroup).
Stroke volume optimization group (SVO group):
Colloid aliquots of 200 ml 6% hydroxy ethyl starch 130/ 0.4 (Voluven, Fresenius kabi, Deutschland GmbH, Bad Homburg, Germany) will be administered within 10 minutes and stroke volume response will be recorded .If stroke volume increase by more than 10 % for 20 minutes, the aliquot will be repeated. No further aliquots will be given once stroke volume failed to increase >10%. The last stroke volume without rise of > 10% will be defined as optimum stroke volume (SVopt).When stroke volume decreases by 10% below (SVopt), this will be defined as trigger stroke volume (SVT). Stroke volume will be followed every 30 minutes during surgery and every 4 hours for 24 hours postoperatively .
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The management will be carried out by a member of research team only aware of allocation group. The attending anesthesiologist, surgeons and nursing staff will be totally blind of randomization schedule or the hydration regimen used. All postoperative clinical staff handling patient care will be also unaware of the aim of the work.
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 patients with American Society of Anesthesiologists (ASA) physical status I - II scheduled for radical cystectomy and urinary diversion for muscle invasive urinary bladder carcinoma .
- •Both sexes
排除标准
- •Patients younger than 18 years
- •Body mass index (BMI) < 25 and >
- •Patients with any contraindications to epidural anesthesia (patient refusal, local skin infection, previous spine surgery and coagulopathy).
- •Those with known allergy to local anesthetics.
- •Patients with major cardiovascular problems with ejection fraction < 40 .
- •Renal impairment with serum creatinine >1.8 mg/dl
- •Patients with hepatic dysfunction will be excluded.
结局指标
主要结局
Perioperative hypotension
时间窗: perioperative
Mean arterial blood pressure \< 65mmHg
Maximal tissue oxygenation
时间窗: perioperative
Oxygen delivery index \> 550 ml/min/m2
次要结局
- Medical postoperative complication(48 hours postoperative)
- Anesthetic postoperative complication(24 hours postoperative)
- Respiratory postoperative complication(7-days postoperative)
- Postoperative complication(7-days postoperative)
- Surgical postoperative complication(7-days postoperative)
研究者
Mahmoud Mahmoud Othman
professor of Anesthesia and surgical ICU
Mansoura University