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)
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Myocardial Injury assessed by changes in Troponin values
研究概览
简要总结
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 (sevo \propofol)
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery.
排除标准
- •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)
- •Known intolerance/allergy to sevoflurane or propofol
研究组 & 干预措施
Sevofluorane
Patients preconditioned with Sevo
干预措施: sevofluorane (Drug)
结局指标
主要结局
Myocardial Injury assessed by changes in Troponin values
时间窗: properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest
According to the routine post operative blood testing frame-time troponin sample will collected in the preoperative and postoperative period.
次要结局
未报告次要终点
研究者
MOSCARELLI MARCO
MD, PhD
Fondazione Toscana Gabriele Monasterio