Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic Prostaectomy
Effect Of Standard Versus Restricted Fluid Therapy Guided By Electric Cardiometry On Tissue Perfuison In Robotic Prostaectomy: A Randomized Controlled Study
Fluid therapy during surgery is an important factor that is related to long term mortality and morbidity and it's directly related to tissue perfusion as well. The main target in any surgery is what is the optimum fluid therapy to maintain the tissue perfusion and the precise balance between hazardous effects of hypervolemia that may cause delayed wound healing due to surgical anastomosis disruption or being hypovolemic that may cause tissue ischemia as acute kidney injury.
Fluid management guidance changed from static methods like central venous pressure into dynamic methods like pulse pressure variation (PPV) and stroke volume variation (SVV), which are now the most famous dynamic measures.
Electrical cardiometry is a non-invasive cardiac output monitor which uses electrical cardiometry, now a commonly used device, to measure SVV which can be used to guide fluid therapy during surgeries.
Now robotic assisted surgery is a common method in preforming many surgeries especially urological, since it's associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function.
With considerations related to severe Trendelenburg position and increased intra-abdominal pressure due to pneumo-peritoneum, robotic assisted surgeries are associated with many challenges in anesthesia especially the fluid therapy.
Fluid therapy in robotic surgeries is an area with growing research focus that need further exploration while there are established guidelines for fluid management in traditional surgeries, the optimal protocols for robotic surgeries are less well defined, needing more research.
We aim at this study to investigate the impact of liberal versus restricted fluid intake on the tissue perfusion reflected by serum lactate & creatinine clearance, while guiding therapy through electrical cardiometry, to reach optimum fluid protocol in prostatic robotic surgeries.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Mohamed M Mohamed, M.Sc.
- 电话号码:+20 111 8370641
- 邮箱:mandamembo0@gmail.com
研究联系人备份
- 姓名:Nazmy S Mikhael, M.D.
- 电话号码:+20122 7400808
- 邮箱:drnazmyseif@kasralainy.edu.eg
学习地点
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Cairo、埃及
- 招聘中
- Cairo university hospitals
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接触:
- Mohamed M Mohamed, M.Sc.
- 电话号码:+20 111 8370641
- 邮箱:mandamembo0@gmail.com
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接触:
- Nazmy S Mikhael, M.D.
- 电话号码:+201227400808
- 邮箱:drnazmyseif@kasralainy.edu.eg
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male patient undergoing robotic assisted prostatectomy
- ASA I-III
Exclusion Criteria:
- ASA score more than III
- BMI more than 40
- Severe renal disease (GFR between 15 and 29)
- Previous renal surgery.
- Decompensated cardiac disease (NYHA class 3 or 4)
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Liberal Group
Liberal Fluid Therapy Group
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Patients will receive 6 ml/kg/hour of lactated ringer for maintenance in addition to fasting hours compensation (2 ml/kg for each fasting hour, given as 50% in the first hour of surgery, then 25% during the second & third hours).
An additional bolus of 200 ml Lactated Ringer will be given if MAP is below 65 mmHg.
In case of persistent hypotension despite proper fluid rescuistation, 10 mg of Ephedrine will be administered; if no response is achieved, norepinerhine infusion will start at initial dose 0.01mcg/kg/min if MAP is below 65 mmHg.
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有源比较器:Restricted Group
Restricted Fluid Therapy Group
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Patients will receive 2 ml/kg as fluid bolus then 2 ml/kg/hour for maintenance, aiming at a target SVV less than 13 %.
Patients with SVV ≥ 13% will be considered fluid responder and will receive a fluid bolus of 200 ml Ringer Lactated Ringer over 10 minutes.The fluid bolus will be repeated until the SVV is less than 13%.
In case of persistent hypotension (MAP less than 65mmHg), 10 mg of Ephedrine will be administered; if no response is achieved, norepinerhine infusion will be started at intial dose 0.01mcg/kg/min if MAP is below 65 mmHg.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum Lactate level difference
大体时间:24 hours
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Serum Lactate level difference between pre-operative (baseline) value and post-operative (recovery) value in mmol/L
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24 hours
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合作者和调查者
调查人员
- 学习椅:Ashgan R Aly, M.D.、Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
- 首席研究员:Nazmy S Mikhael, M.D.、Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
- 研究主任:Mohamed M Mohamed, M.Sc.、Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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