Preconditioning With Sevoflurane and Propofol in Patients Undergoing Minimally Invasive Mitral Valve Surgery

• Conditions: Myocardial Ischemia
• Interventions: Drug: sevofluorane

• Registration Number: NCT02551328
• Lead Sponsor: Fondazione Toscana Gabriele Monasterio

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).

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-09
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-15
• Last Update Submitted: 2015-09-15
• Study First Posted: 2015-09-16
• Last Update Posted: 2015-09-16
• Primary Completion: 2016-03
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sevofluorane	sevofluorane	Patients preconditioned with Sevo

Primary Outcome Measures

Name	Time	Method
Myocardial Injury assessed by changes in Troponin values	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.

Trial Locations

Locations (1)

Ospedale del cuore, Pasquinucci Hospital, Fondazione Monasterio; 🇮🇹 Massa, Italy