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

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02551328
Acronym
MINI-SEVO
Enrollment
48
Registered
2015-09-16
Start date
2015-06-30
Completion date
2016-09-30
Last updated
2015-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

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).

Interventions

Continuous infusion of sevofluorane

Sponsors

Fondazione Toscana Gabriele Monasterio
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Myocardial Injury assessed by changes in Troponin valuesproperatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrestAccording to the routine post operative blood testing frame-time troponin sample will collected in the preoperative and postoperative period.

Countries

Italy

Contacts

Primary ContactAlessandra Parlanti, Pharmacist
alessandra.parlanti@ftgm.it-parlantialessandra@gmail.com0039/0585/493675/493565

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026