Sevoflurane in Cardiac Surgery (SEVO AIFA)

• ClinicalTrials.gov Identifier: NCT00821262
• Recruitment Status: Completed
• First Posted: January 13, 2009
• Last Update Posted: October 14, 2015
• Sponsor: Università Vita-Salute San Raffaele
• Information provided by (Responsible Party): Giovanni Landoni, Università Vita-Salute San Raffaele

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia; Cardiac Surgery	Drug: sevoflurane; Drug: propofol	Phase 4

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Sevoflurane and Cardiac Protection in High Risk Patients Undergoing Cardiac Surgery. A Randomized Controlled Study.
• Study Start Date: September 2008
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: sevoflurane; The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).	Drug: sevoflurane
Active Comparator: propofol; The control group will receive propofol for the same 4-6 hours period.	Drug: propofol

Outcome Measures

Primary Outcome Measures :

1. Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay

Secondary Outcome Measures :

1. cardiac troponin release
2. incidence of perioperative myocardial infarction
3. time on mechanical ventilation
4. postoperative hospital stay

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Italy

Vita-Salute University

Milano, Italy

Azienda Ospedaliera di Padova

Padova, Italy

Azienda Ospedaliera di Perugia (H Santa Maria della Misericordia)

Perugia, Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

Università La Sapienza, Policlinico Umberto I, Roma

Roma, Italy

Sponsors and Collaborators

Università Vita-Salute San Raffaele

Investigators

• Principal Investigator: giovanni landoni, MD; Vita-Salute University of Milano. Italy
• Study Director: elena bignami, MD; Vita-Salute University of Milano, Italy

More Information

Additional Information:

ITACTA (Italian Association of Cardiothoracic Anesthesiologists) 

Publications:

Landoni G, Biondi-Zoccai GG, Zangrillo A, Bignami E, D'Avolio S, Marchetti C, Calabrò 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. Epub 2007 May 7. Review.

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. Review.

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.

Landoni G, Calabrò 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. Epub 2007 Feb 22.

Tritapepe L, Landoni G, Guarracino F, Pompei F, Crivellari M, Maselli D, De Luca M, Fochi O, D'Avolio S, Bignami E, Calabrò 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. 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.

Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. Epub 2009 Sep 1. Review.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Giovanni Landoni, DM, Università Vita-Salute San Raffaele
• ClinicalTrials.gov Identifier: NCT00821262
• Other Study ID Numbers: GO/URC/ER/mm 412/DG
• First Posted: January 13, 2009
• Last Update Posted: October 14, 2015
• Last Verified: October 2015

Keywords provided by Giovanni Landoni, Università Vita-Salute San Raffaele:

Sevoflurane; Anesthesia; Troponin; Myocardial Preconditioning; Surgery, Cardiac; Stents; Non-cardiac Surgery; Surgery

Additional relevant MeSH terms:

Propofol; Sevoflurane; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation