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临床试验/NCT05537246
NCT05537246已完成不适用

The Importance of Preoperative Arterial Stiffness Measurement in Predicting Hemodynamic Changes in Hypertensive and Normotensive Patients Undergoing Spinal Anaesthesia

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2021年9月1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
124
试验地点
2
主要终点
Arterial blood pressure

研究概览

简要总结

The aim of this study is to investigate the importance of pulse wave velocity, an indicator of arterial stiffness, in predicting hemodynamic changes in normotensive and hypertensive patients undergoing spinal anesthesia.

详细描述

The prospective cross-sectional study will be carried out between September 1, 2021 and September 1, 2022 at Aydin Adnan Menderes University Faculty of Medicine. Patients aged eighteen and over who will undergo lower extremity surgery under spinal anesthesia will be included in the study.

During the preoperative evaluation, the patient will be asked about age, weight, height, smoking and alcohol use history. At the same time, hypertension disease (if any, drugs used), diabetes (if any, drugs used), hyperlipidemia (if any, drugs used) and other diseases and drugs used will be recorded.

Before surgery, hemodynamic data (systolic arterial blood pressure, diastolic arterial blood pressure, mean arterial blood pressure, heart rate and oxygen saturation), arterial stiffness measurement (pulse wave velocity) will be evaluated in the patient preparation room. Arterial stiffness measurement will be made with the oscillometric mobil-o-graph device in the anesthesia department.

Hemodynamic data is recorded by the anesthesia device 1.,3.,5.,10.,20. minutes during surgery. Intraoperative hypotension is accepted as a 20% reduction in systolic arterial blood pressure evaluated before anesthesia. Using this data recorded on the monitor, reductions of 20% or more in systolic arterial blood pressure will be recorded as hypotension.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing elective lower extremity surgery
  • 18 years and over
  • who agreed to participate in the study

排除标准

  • Undergoing cardiovascular or neurological surgery within 6 months
  • Unwilling to participate in the study
  • Undergoing prosthetic valve surgery
  • Vasculitis
  • Peripheral artery disease
  • Under the age of 18
  • Conditions in which spinal anesthesia is contraindicated

结局指标

主要结局

Arterial blood pressure

时间窗: 1., 3., 5., 10., 20. minute

After spinal anesthesia, SBP, DBP, MAP, HR and SpO₂ values of all patients were recorded.

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SİNAN YILMAZ

Associate Professor

Aydin Adnan Menderes University

研究点 (2)

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