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

Myocardial Ischemia Clinical Trial

— MINI-SEVO  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02551328
• Other study ID #: 452/2014
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2015
• Last updated: September 15, 2015
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: Fondazione Toscana Gabriele Monasterio
• Contact: Alessandra Parlanti, Pharmacist
• Phone: 0039/0585/493675/493565
• Email: alessandra.parlanti[@]ftgm.it-parlantialessandra[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• sevofluorane
Continuous infusion of sevofluorane

Locations

Country	Name	City	State
Italy	Ospedale del cuore, Pasquinucci Hospital, Fondazione Monasterio	Massa

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Toscana Gabriele Monasterio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Injury assessed by changes in Troponin values	According to the routine post operative blood testing frame-time troponin sample will collected in the preoperative and postoperative period.	properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest	No