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临床试验/NCT05502835
NCT05502835已完成不适用

Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Intraoperative fluid volume

研究概览

简要总结

pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.

详细描述

All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group):

Group A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution.

Group B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
  • •Patients scheduled for elective open colonic mass resection and anastomosis.

排除标准

  • •Serious cardiac arrhythmia.
  • •Peripheral artery disease.
  • •An ejection fraction below 30%.
  • •A pulmonary pathology.

研究组 & 干预措施

conventional fluid management group

Experimental

patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution.

干预措施: conventional fluid management (Other)

ppv group

Active Comparator

patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

干预措施: pulse pressure variation (Device)

结局指标

主要结局

Intraoperative fluid volume

时间窗: calculated immediately after surgery

次要结局

  • intraoperative blood pressure(every ten minutes till the end of the surgery)
  • lactate level(every hour till the end of the surgery)
  • POSTOPERATIVE COMPLICATIONS(till one week after surgery)
  • intestinal oedema(intraoperatively after tumor resection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

研究点 (1)

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