Preconditioning With Sevoflurane and Propofol in Patients Undergoing Minimally Invasive Mitral Valve Surgery (MINI-SEVO)

Fondazione Toscana Gabriele Monasterio

Status: Unknown

Conditions: Myocardial Ischemia

Treatments: Drug: sevofluorane

Study type: Observational

Funder types: Other

Identifiers

NCT02551328

452/2014

Details and patient eligibility

About

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)

Full 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).

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18
2. Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery.

Exclusion criteria

1. Cardiogenic shock or cardiac arrest, emergent CABG
2. Renal failure (with a GFR < 30 ml/min/1.73m2),
3. Glibenclamide or nicorandil (as these medications may interfere with VC)
4. Pregnancy
5. Known intolerance/allergy to sevoflurane or propofol

Trial design

48 participants in 2 patient groups

Sevofluorane

Description:

Patients preconditioned with Sevo

Treatment:

Drug: sevofluorane

Propofol

Description:

Patients with no preconditioning