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临床试验/NCT03389607
NCT03389607已完成不适用

The Role of SCUBE-1 in Ischemia-reperfusion Injury in Patients With Knee Prosthesis

Diskapi Yildirim Beyazit Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
SCUBE-1

研究概览

简要总结

One consequence of tissue damage caused by tourniquet is ischemia-reperfusion injury. Short-term ischemia leads to vasodilatation and reactive hyperemia resulting in post-ischemic reperfusion microcirculation failure and tissue edema that extends from 30 minutes to 4 hours.

SCUBE-1 is a newly defined cell surface molecule. It emerges from many developing cells, including endothelium and platelets. Immunohistochemical demonstration of subendothelial matrix deposition in atherosclerosis in humans. We did not find any study that showed the post-ischemic regression of scube 1, which was shown to be significantly higher in ischemic events in the literature.

in this study is aimed to investigate the location / sensitivity of SCUBE-1 in diabetics and nondiabetics after application of regional anesthesia for ischemia-reperfusion injury induced by tourniquet application in knee prosthesis attempts in our aimed patients and compare this with other total antioxidant status (TAS) and MDA of ischemia-reperfusion parameters

详细描述

After being taken to the operation room, the patient will be divided into two groups as group D (diabetic) and group K (control) by standardized anesthesia monitoring with 5-lead electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure measurements.

In both groups, spinal anesthesia will be applied in a lateral decubitus position using a 22 gauge Quincke spinal needle from the interspinal space as 0.5% heavy marcaine 10-12.5 mg 1 min. Atropine 0.5 mg and ephedrine 5 mg should be administered if bradycardia develops in both groups. The disease tourniquet will be applied after induction, in accordance with the literature, to be above 150 mmHg of the systolic blood pressure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Diabetes mellitus
  • knee replacement surgery
  • using a pneumatic tourniquet

排除标准

  • coronary artery disease
  • renal disorders
  • cognitive disorders
  • bleeding diathesis
  • who have passed general anesthesia
  • anti-inflammatory drugs treatment
  • abnormal HbA1c values

结局指标

主要结局

SCUBE-1

时间窗: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation

mean level of SCUBE-1

次要结局

  • malondialdehyde (MDA)(before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation)
  • total antioxidant capacity(before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation)

研究者

发起方
Diskapi Yildirim Beyazit Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Savas Altinsoy

principal investigator

Diskapi Yildirim Beyazit Education and Research Hospital

研究点 (1)

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