Skip to main content
Clinical Trials/NCT02551328
NCT02551328
Unknown
Not Applicable

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)

Fondazione Toscana Gabriele Monasterio1 site in 1 country48 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
sevofluorane
Conditions
Myocardial Ischemia
Sponsor
Fondazione Toscana Gabriele Monasterio
Enrollment
48
Locations
1
Primary Endpoint
Myocardial Injury assessed by changes in Troponin values
Last Updated
10 years ago

Overview

Brief Summary

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)

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
September 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

MOSCARELLI MARCO

MD, PhD

Fondazione Toscana Gabriele Monasterio

Eligibility Criteria

Inclusion Criteria

  • 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)
  • Known intolerance/allergy to sevoflurane or propofol

Arms & Interventions

Sevofluorane

Patients preconditioned with Sevo

Intervention: sevofluorane

Outcomes

Primary Outcomes

Myocardial Injury assessed by changes in Troponin values

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials