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临床试验/NCT06133257
NCT06133257尚未招募不适用

Effects of Goal-Directed Fluid Therapy Guided by Inferior Vena Cava Collapsibility Index on Hemodynamics and Enhanced Recovery in Patients Undergoing Lower Limb Surgeries

Zagazig University0 个研究点目标入组 52 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
主要终点
Mean Arterial Blood Pressure

研究概览

简要总结

Controlling the amount of fluids given to patients in perioperative setting can significantly influence their outcomes.

详细描述

To overcome these problems and avoid the complications of over or underhydration, we use the Goal-directed fluid therapy(GDFT) guided by Inferior vena cava(IVC) collapsibility index approach in which dynamic parameters of volume responsiveness as a guide for fluid therapy. This will ensure that the fluids given were deficient from the circulation and improve the recovery of the patients according to enhanced recovery after surgery(ERAS) protocols.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient's acceptance.
  • Patients planned for elective lower limb surgery under spinal anesthesia.
  • Both sexes
  • Body Mass Index(BMI): <35
  • Age: 21 ~ 65 years
  • American Society of Anesthesiologists(ASA) Physical Status Classification System: Class I & II
  • Duration of surgery 2~3 hours

排除标准

  • Advanced kidney, liver, respiratory or cardiovascular disease.
  • Contraindication for spinal anesthesia.
  • Patients shifted to general anesthesia for any reason.

结局指标

主要结局

Mean Arterial Blood Pressure

时间窗: intraoperatively every 5 minutes

intraoperative mean arterial blood pressure measured in mmHg

Quality of Recovery-40 score(QoR-40)

时间窗: 24 hours postoperative

QoR-40 score ranges from 40 to 200, the higher the score the better the outcome

Heart Rate

时间窗: intraoperatively every 5 minutes

intraoperative heart rate will be continuously monitored and recorded every 5 minutes

Post Anesthesia Care Unit(PACU) Stay

时间窗: 2 hours postoperatively

time spent in PACU after surgery measured in minutes

次要结局

  • Total fluid intake during operation(intraoperatively)
  • Number of patients that needed Ephedrine or Atropine(intraoperatively)
  • Length of hospital stay(the patient will be followed up for 60 days from day of surgery)
  • Peripheral perfusion index(Intraoperatively)

研究者

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

Mahmoud Aboubakr Abdelkader

resident doctor of anesthesia, Intensive Care and Pain Management

Zagazig University

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