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临床试验/NCT05774067
NCT05774067已完成不适用

Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty

Tanta University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
change of mean arterial blood pressure

研究概览

简要总结

Pneumatic tourniquet is usually used in orthopedic surgeries, as it helps to decrease operative bed bleeding, and thus, maintaining a clean and dry surgical field allowing easy and clear identification of the anatomical structures. Despite that advantage, after its deflation, there is a blood volume shift towards that ischemic area, which may decrease cardiac preload leading to hypotension

详细描述

Hemodynamic changes after tourniquet deflation include; hypotension, tachycardia and increase in cardiac index. These changes may be insignificant for healthy individuals but, risky for patients with compromised cardiovascular system and geriatric population.

Hypovolemia is a common problem in many clinical situations. The mortality of hypovolemic shock is directly related to the severity and duration of organ hypoperfusion.

Management of hypotension include frequent monitoring of blood pressure, fluid therapy, non-pharmacological methods, and vasopressors. Fluid therapy by crystalloids or colloids has been the traditional approach to restore volume and can be given as preload or co-load .Non pharmacological methods include positioning and leg compression. Trendelenburg position can increase venous return to the heart. Leg compression by flexion of the hip, elastic bandages, or stockings. An efficient method to treat spinal hypotension is administration of vasopressors, either given by infusion or boluses. Vasopressor drugs act by reversing the circulatory effect of sympathetic blockade. They also restore vascular tone and preserve venous return and cardiac filling

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Adult Patients of both gender
  • American Society of Anesthesiologists (ASA) I or II
  • scheduled for elective unilateral total knee arthroplasty
  • Exclusion Criteria
  • Patient refusal.
  • Major cardiopulmonary disorders
  • Uncontrolled systemic hypertension.
  • Hepatic or renal disorders.
  • Patient with relative contraindication for tourniquet use as peripheral vascular disease, sickle cell anemia, deep venous thrombosis, diabetic neuropathy and crushed injury.
  • Cases having American Society of Anesthesiologists [ASA] > II
  • Coagulopathy and bleeding tendency.
  • Revision knee arthroplasty and bilateral knee arthroplasty

排除标准

  • 未提供

研究组 & 干预措施

control

Active Comparator

干预措施: Saline (Drug)

noradrenaline

Active Comparator

干预措施: Norepinephrine (Drug)

glypressin

Active Comparator

干预措施: glypressin (Drug)

结局指标

主要结局

change of mean arterial blood pressure

时间窗: 30 minutes after tourniquet deflation

change of mean arterial bllod pressure till 30 min after deflation of the tourniquet.

次要结局

未报告次要终点

研究者

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

tarek abdel hay mostafa

principle investigator

Tanta University

研究点 (1)

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