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临床试验/NCT02407626
NCT02407626终止不适用

Optimierung Der Kardioprotektion Durch Inhalative Anästhetika Eine Untersuchung Bei Patienten Mit Diabetes Mellitus während Off-pump Herzchirurgie

Triemli Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Biomarker NT-proBNP

研究概览

简要总结

This study evaluates the myocardial protection against perioperative ischemia comparing two standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of the patients will receive volatile anesthesia while the other half will receive total intravenous anesthesia. Primary and secondary outcome parameters will be assessed after induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.

详细描述

Volatile anaesthetics such as Sevoflurane have shown to have a protective effect regarding myocardial ischemia in the perioperative setting - the so-called "preconditioning". However the observed response of preconditioning in clinical trials is not consistent.

An increased perioperative insulin resistance especially in diabetic patients resulting in an increased postoperative morbidity and mortality may be responsible for these findings.

In an animal model, the use of propofol that is being routinely applied for general anesthesia was associated with a change of the insulin receptor substrate via phosphorylation and thus a change of insulin resistance.

Avoiding a total intravenous anesthesia and applying a volatile anesthesia may result in an increased cardioprotective effect by a reduction of the perioperative insulin resistance.

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
40 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Elective cardiac surgery

排除标准

  • Emergency procedures
  • Preop myocardial infarction
  • Preop cardiac failure
  • Preop renal replacement therapy

研究组 & 干预措施

Sevoflurane

Experimental

Volatile anesthesia for elective cardiac surgery

干预措施: Sevoflurane (Drug)

Propofol

Active Comparator

Total intravenous anesthesia for elective cardiac surgery

干预措施: Propofol (Drug)

结局指标

主要结局

Biomarker NT-proBNP

时间窗: 1. after induction of anesthesia 2. after chest closure 3.-5. postoperative day 1, day 2, day 3

Difference between volatile anesthesia and total intravenous anesthesia

次要结局

  • Expression of TNF/IL1beta and microRNA (miR144, miR125b, miR208a)(1. beginning of cardiac surgery, 2. end of cardiac surgery)
  • Receptor Substrate phosphorylization (IRS-1)/PP2A(1. beginning of cardiac surgery, 2. end of cardiac surgery)

研究者

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

Christoph K Hofer

Prof. Dr. med.

Triemli Hospital

研究点 (1)

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