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临床试验/NCT05340946
NCT05340946已完成不适用

Comparison of the Effect of Two Anaesthesia Methods in Preventing Perioperative Myocardial Infarction in Patients With Cardiac Risk Undergoing Total Knee Arthroplasty

Alexandria University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
brain natriuretic peptide

研究概览

简要总结

Comparison of the effect of two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty

详细描述

we enrolled 50 patients of both sex of American society of Anesthesiologists (ASA) physical status II where the presence and/or risk for coronary artery disease (CAD) as well as planned lower extremity surgery was considered. Presence of CAD was ascertained by history of myocardial infarction and diagnosis of typical angina or atypical angina with a positive stress test & ECG finding. Risk for CAD included age (> 65 years old), hypertension, smoking habit, blood cholesterol (>240 mg/dL), and diabetes. who met the selection criteria were randomly allocated to 1 of the 2 groups (25 patients) each:

  • Group (G): received general anaesthesia followed by IV patient-controlled analgesia (IV PCA).
  • Group (F): received spinal anaesthesia followed by continuous ultrasound guided femoral never block once the anaesthesia-induced motor block resolved. We aimed to compare the effect of the two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty. The primary outcome included perioperative levels of brain natriuretic peptide & cardiac troponins. Secondary outcomes included postoperative operative pain assessment using visual analogue scale, total amount of analgesic consumption, patient satisfaction & cardiovascular complications (myocardial infarction, arrhythmias , heart failure, hypotension, hypertension & the need for inotropic agents).

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
None

入排标准

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

入选标准

  • presence and/or risk for coronary artery disease (CAD) as well as planned lower extremity surgery was considered. Presence of CAD was ascertained by history of myocardial infarction and diagnosis of typical angina or atypical angina with a positive stress test & ECG finding. Risk for CAD included age (> 65 years old), hypertension, smoking habit, blood cholesterol (>240 mg/dL), and diabetes.

排除标准

  • severe impairment of left ventricular function (ejection fraction < 40 %). 2) renal failure requiring hemodialysis. 3) known allergies to the drugs used in the present study. 4) contraindications to regional blocks (localized infection, and use of an antiplatelet drug within 3 days before the surgery). 5) unusual blood coagulation tests.

结局指标

主要结局

brain natriuretic peptide

时间窗: after 48 hours post-operatively

marker for myocardial infarction

次要结局

  • visual analogue scale(after 6 hour postoperatively)
  • amount of analgesic consumption(after 48 hour postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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