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临床试验/NCT00364637
NCT00364637已完成4 期

Pharmacological Preconditioning Properties of Volatile Anesthetics

Università Vita-Salute San Raffaele1 个研究点 分布在 1 个国家开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
试验地点
1
主要终点
Reduce postprocedural cardiac troponin release

研究概览

简要总结

Patients undergoing stenting procedures, or cardiac or non-cardiac surgery could develop myocardial damage as testified by cardiac troponin release.

Sevoflurane (volatile anesthetic), routinely used in cardiac and non-cardiac anesthesia, has cardioprotective properties that could be useful to reduce cardiac damage, as indicated by cardiac troponin release in different contexts:

  • stenting procedures (periprocedural administration)
  • non-cardiac surgery (during the whole procedure)
  • cardiac surgery (during the whole procedure)

详细描述

Stenting procedures, cardiac and non-cardiac surgical procedures may carry a significant risk of cardiac damage ultimately leading to prolonged hospital stay and even a non-negligible periprocedural mortality rate. According to the American College of Cardiology/American Heart Association Guidelines all anesthetic techniques and drugs have known cardiac effects that should be considered in the perioperative plan. There appears to be no one best myocardium protective anesthetic technique: the choice of anesthesia is best left to the discretion of the anesthesia care team. To date no anesthesiological drug or techniques proved to reduce perioperative morbidity and mortality in cardiac surgery, only Beta-blockers and locoregional analgesia showed improved outcomes after non-cardiac surgery and no study on anesthesiological drugs has been performed in stenting procedures.

Volatile anesthetics, which are commonly used in general anesthesia to induce and maintain hypnosis, analgesia, amnesia and mild muscle relaxation, have been shown to improve post-ischemic recovery at the cellular level, in isolated hearts, and in animals, both through a pharmacological preconditioning and postconditioning action. Whether the cardioprotective effects of volatile anesthetics are clinically applicable and associated with improved cardiac function, ultimately resulting in a better outcome in patients undergoing cardiac surgery, is still debated. No data exist on patients undergoing non-cardiac surgery or stenting procedures.

A recently published meta-analysis including studies considering all volatile anesthetics showed no reduction in myocardial infarction and perioperative death rate. However the newer volatile anesthetics (desflurane and sevoflurane) seem to have more prominent cardioprotective properties and numerous apparently positive reports targeted to surrogate end-points, yet severely underpowered, have appeared in the literature. Of interest, many of these studies were not included in the above cited meta-analysis.

To address the question of whether the choice of an anesthetic regimen might influence patients' outcome we have planned a RCT to determine the impact of sevoflurane on perioperative cardiac damage in patients undergoing cardiac surgery, non-cardiac surgery and stenting procedures.

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, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cardiac surgery
  • Non-cardiac surgery
  • Stenting procedures

排除标准

  • Age < 18 years old
  • Not signing written consent

研究组 & 干预措施

Total intravenous anesthesia

Active Comparator

干预措施: Total intravenous anesthesia (Drug)

sevoflurane

Experimental

干预措施: Sevoflurane (Volatile Anesthetic) (Drug)

结局指标

主要结局

Reduce postprocedural cardiac troponin release

次要结局

  • Reduce time on mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
  • mortality

研究者

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

Giovanni Landoni

DM

Università Vita-Salute San Raffaele

研究点 (1)

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