Preconditioning With Sevoflurane and Propofol in Patients Undergoing Minimally Invasive Mitral Valve Surgery (MINI-SEVO)
A Single-center Observational Study Investigating the Effect of Volatile Conditioning (VC) With Sevoflurane on Myocardial Biomarkers and Platelets Function in Patients Having Minimally Invasive Mitral Valve Surgery (MIMV)
研究概览
详细说明
The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes:
- Volatile conditioning (sevoflurane) used during induction (preconditioning) and during the operation as maintenance (perconditioning) and no propofol.
- Propofol induction and maintenance (TIVA) and no volatile anaesthetics.
Outlet/residual blood samples coming from routine check will be collected at different time points.
Study will be powered on Troponin I (primary statistical outcome). Original secondary outcome will be considered: platelets activation, left ventricle function, clinical figures (length of stay, inotrops requirements, ventilation times and other relevant).
研究类型
注册 (预期的)
联系人和位置
学习地点
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Massa、意大利
- 招聘中
- Ospedale del cuore, Pasquinucci Hospital, Fondazione Monasterio
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接触：
- Marco Moscarelli, MD
- 电话号码：0044 07587163062
- 邮箱：m.moscarelli@imperial.ac.uk
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接触：
- Dorela Haxhiademi, MD
- 邮箱：dorela_h@yahoo.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age ≥18
- Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery.
Exclusion Criteria:
- Cardiogenic shock or cardiac arrest, emergent CABG
- Renal failure (with a GFR < 30 ml/min/1.73m2),
- Glibenclamide or nicorandil (as these medications may interfere with VC)
- Pregnancy
- Known intolerance/allergy to sevoflurane or propofol
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Sevofluorane
Patients preconditioned with Sevo
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Continuous infusion of sevofluorane
其他名称：
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Propofol
Patients with no preconditioning
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Myocardial Injury assessed by changes in Troponin values
大体时间：properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest
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According to the routine post operative blood testing frame-time troponin sample will collected in the preoperative and postoperative period.
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properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest
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合作者和调查者
调查人员
- 首席研究员：Paolo Del Sarto, MD、Fondazione Toscana Gabriele Monasterio
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.