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Status unknownNCT02551328MINI-SEVOUpdated Sep 16, 2015

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

An observational study in Myocardial Ischemia, sponsored by Fondazione Toscana Gabriele Monasterio. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-16.

Sponsored by Fondazione Toscana Gabriele Monasterio · Observational

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
All
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Study 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)

Read the 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).

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Conditions studied

  • Myocardial Ischemia

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03

In context

Myocardial Ischemia

3,232 studies on the registry are indexed under Myocardial Ischemia; 395 are open to participants now.

This study's planned enrollment of 48 is below the median of 332 across 1,139 observational studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

Fondazione Toscana Gabriele Monasterio is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
48 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sevofluorane

    Patients preconditioned with Sevo

    Drug: sevofluorane

  • Propofol

    Patients with no preconditioning

Interventions

  • Drugsevofluorane

    Continuous infusion of sevofluorane

    Also known as: SEVO

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02551328
Lead sponsor
Fondazione Toscana Gabriele Monasterio
Responsible party
MOSCARELLI MARCO (MD, PhD, Fondazione Toscana Gabriele Monasterio) — Principal investigator
First posted
Sep 16, 2015
Start date
Jun 2015
Primary completion
Mar 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Sep 16, 2015

Study contacts

Alessandra Parlanti, Pharmacist
Contact
alessandra.parlanti@ftgm.it-parlantialessandra@gmail.com
0039/0585/493675/493565
Paolo Del Sarto, MD
principal investigator · Fondazione Toscana Gabriele Monasterio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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