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

September 15, 2015 updated by: MOSCARELLI MARCO, Fondazione Toscana Gabriele Monasterio

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)

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Age>=18 Pt undergoing elective (or urgent) first-time minimal invasive mitral valve surgery Pt will have to sign informed consent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sevofluorane
Patients preconditioned with Sevo
Drug: sevofluorane
Continuous infusion of sevofluorane
Other Names:
  • SEVO
Propofol
Patients with no preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Toscana Gabriele Monasterio

Investigators

  • Principal Investigator: Paolo Del Sarto, MD, Fondazione Toscana Gabriele Monasterio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 452/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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