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

NCT ID: NCT02551328

Last Updated: 2015-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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).

Conditions

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Myocardial Ischemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sevofluorane

Patients preconditioned with Sevo

sevofluorane

Intervention Type DRUG

Continuous infusion of sevofluorane

Propofol

Patients with no preconditioning

No interventions assigned to this group

Interventions

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sevofluorane

Continuous infusion of sevofluorane

Intervention Type DRUG

Other Intervention Names

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SEVO

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Toscana Gabriele Monasterio

OTHER

Sponsor Role lead

Responsible Party

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MOSCARELLI MARCO

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Del Sarto, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Toscana Gabriele Monasterio

Locations

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Ospedale del cuore, Pasquinucci Hospital, Fondazione Monasterio

Massa, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandra Parlanti, Pharmacist

Role: CONTACT

0039/0585/493675/493565

Facility Contacts

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Marco Moscarelli, MD

Role: primary

0044 07587163062

Dorela Haxhiademi, MD

Role: backup

Other Identifiers

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452/2014

Identifier Type: -

Identifier Source: org_study_id

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