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- Essai clinique NCT00821262
Sevoflurane in Cardiac Surgery (SEVO AIFA)
Sevoflurane and Cardiac Protection in High Risk Patients Undergoing Cardiac Surgery. A Randomized Controlled Study.
Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.
The investigators want to document whether the cardioprotective properties of volatile agents could translate in an improved outcome after cardiac surgery in high risk patients.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background
It is commonly believed that the choice of the primary anesthetic agent does not result in different outcomes after cardiac surgery. Recent evidence however has indicated that volatile anesthetics improve post-ischemic recovery. These results have been summarized in a meta-analysis of 22 randomized studies, involving 1922 patients: the use of volatile anesthetics was associated with significant reductions of myocardial infarctions (24/979 [2.4%] in the volatile anesthetics group vs 45/874 [5.1%] in the control arm, odds ratio [OR]=0.51 [0.32-0.84], and mortality (4/977 [0.4%] vs 14/872 [1.6%], OR=0.31 [0.12-0.80].
Furthermore, the use of volatile anesthetics was associated with shorter intensive-care unit stay (WMD=-7.10 hours [-11.47; -2.73], and time to hospital discharge (WMD=-2.26 days [-3.83; -0.68].
All the studies of the meta-analysis included low risk patients undergoing isolated procedures (mostly coronary artery bypass grafting).
Objectives
Investigators are planning a large multicentre randomized controlled study to confirm the beneficial cardioprotective effects of volatile anesthetics in cardiac surgery as indicated by a reduced intensive care stay and/or death in an high risk population of patients undergoing combined valvular and coronary procedures. Secondary endpoints will be: cardiac troponin release; incidence of myocardial infarction; time on mechanical ventilation; postoperative hospital stay
Methods
Various centers will randomize 200 patients to receive either a total intravenous anesthesia with propofol or an anesthesia with sevoflurane. All patients will receive a standard middle dose opiates anesthesia. All the perioperative management will be otherwise identical and standardized. Transfer out of the intensive care will be performed with SpO2 94% or greater at an FiO2 of 0.5 or less by facemask, adequate cardiac stability with no hemodynamically significant arrhythmias, chest tube drainage less than 50 ml/h, urine output greater than 0.5 ml/kg/h, no intravenous inotropic or vasopressor therapy in excess of dopamine 5 ug/kg/min, and no seizure activity.
Expected Results
The reduced cardiac damage (reduction in cardiac troponin release and in the incidence of myocardial infarction) will translate into a better tissue perfusion and faster recovery as documented by reduced intensive care unit.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Milano, Italie
- Vita-Salute University
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Padova, Italie
- Azienda Ospedaliera di Padova
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Perugia, Italie
- Azienda Ospedaliera di Perugia (H Santa Maria della Misericordia)
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Pisa, Italie
- Azienda Ospedaliera Universitaria Pisana
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Roma, Italie
- Università La Sapienza, Policlinico Umberto I, Roma
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- age >18 years
- written informed consent
- scheduled procedures
Exclusion Criteria:
- ongoing acute myocardial infarction
- cardiac troponin >1 ng/ml
- previous unusual response to an anesthetic
- use of sulfonylurea, theophylline or allopurinol
- thoracotomy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: sevoflurane
The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).
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Comparateur actif: propofol
The control group will receive propofol for the same 4-6 hours period.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay
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Mesures de résultats secondaires
Mesure des résultats |
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temps sous ventilation mécanique
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cardiac troponin release
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incidence of perioperative myocardial infarction
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postoperative hospital stay
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: giovanni landoni, MD, Vita-Salute University of Milano. Italy
- Directeur d'études: elena bignami, MD, Vita-Salute University of Milano, Italy
Publications et liens utiles
Publications générales
- Tritapepe L, Landoni G, Guarracino F, Pompei F, Crivellari M, Maselli D, De Luca M, Fochi O, D'Avolio S, Bignami E, Calabro MG, Zangrillo A. Cardiac protection by volatile anaesthetics: a multicentre randomized controlled study in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass. Eur J Anaesthesiol. 2007 Apr;24(4):323-31. doi: 10.1017/S0265021506001931. Epub 2006 Dec 8.
- Guarracino F, Landoni G, Tritapepe L, Pompei F, Leoni A, Aletti G, Scandroglio AM, Maselli D, De Luca M, Marchetti C, Crescenzi G, Zangrillo A. Myocardial damage prevented by volatile anesthetics: a multicenter randomized controlled study. J Cardiothorac Vasc Anesth. 2006 Aug;20(4):477-83. doi: 10.1053/j.jvca.2006.05.012.
- Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.
- Landoni G, Biondi-Zoccai GG, Zangrillo A, Bignami E, D'Avolio S, Marchetti C, Calabro MG, Fochi O, Guarracino F, Tritapepe L, De Hert S, Torri G. Desflurane and sevoflurane in cardiac surgery: a meta-analysis of randomized clinical trials. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):502-11. doi: 10.1053/j.jvca.2007.02.013. Epub 2007 May 7.
- Landoni G, Fochi O, Tritapepe L, Guarracino F, Belloni I, Bignami E, Zangrillo A. Cardiac protection by volatile anesthetics. A review. Minerva Anestesiol. 2009 May;75(5):269-73. Epub 2008 Nov 6.
- Landoni G, Zangrillo A, Fochi O, Maj G, Scandroglio AM, Morelli A, Tritapepe L, Montorfano M, Colombo A. Cardiac protection with volatile anesthetics in stenting procedures. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):543-7. doi: 10.1053/j.jvca.2008.02.020. Epub 2008 May 14.
- Landoni G, Fochi O, Zangrillo A. Cardioprotection by volatile anesthetics in noncardiac surgery? No, not yet at least. J Am Coll Cardiol. 2008 Apr 1;51(13):1321; author reply 1321-2. doi: 10.1016/j.jacc.2007.12.020. No abstract available.
- Landoni G, Calabro MG, Marchetti C, Bignami E, Scandroglio AM, Dedola E, De Luca M, Tritapepe L, Crescenzi G, Zangrillo A. Desflurane versus propofol in patients undergoing mitral valve surgery. J Cardiothorac Vasc Anesth. 2007 Oct;21(5):672-7. doi: 10.1053/j.jvca.2006.11.017. Epub 2007 Feb 22.
- Bignami E, Biondi-Zoccai G, Landoni G, Fochi O, Testa V, Sheiban I, Giunta F, Zangrillo A. Volatile anesthetics reduce mortality in cardiac surgery. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):594-9. doi: 10.1053/j.jvca.2009.01.022. Epub 2009 Mar 19.
- Landoni G, Guarracino F, Cariello C, Franco A, Baldassarri R, Borghi G, Covello RD, Gerli C, Crivellari M, Zangrillo A. Volatile compared with total intravenous anaesthesia in patients undergoing high-risk cardiac surgery: a randomized multicentre study. Br J Anaesth. 2014 Dec;113(6):955-63. doi: 10.1093/bja/aeu290. Epub 2014 Sep 3.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GO/URC/ER/mm 412/DG
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