Volatile Anesthetics to Reduce Mortality in Cardiac Surgery
- Conditions
- Aortocoronary BypassCardiac SurgeryCoronary Artery Bypass Grafting
- Interventions
- Drug: total intravenous anesthetics
- Registration Number
- NCT02105610
- Lead Sponsor
- Università Vita-Salute San Raffaele
- Brief Summary
There is initial evidence that the choice of anesthesia can influence survival in the specific setting of coronary artery bypass grafting surgery (CABG).
A recent international consensus conference included volatile agents among the few drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane) have non-anesthetic pharmacological characteristics that confer cardiac protection when compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin release and mortality in patients receiving volatile anesthetics when compared to patients receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al. 2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can translate into a reduced mortality rate in patients receiving volatile agents. The level of evidence for these four studies is not high (one meta-regression, one underpowered randomized controlled study, one retrospective study and one meta-analysis of small randomized studies) and there is need for a large multicentre randomized controlled study to confirm these findings, as suggested by the international consensus conference on this topic published in 2011 (Landoni et al 2011).
The purpose is to provide a large multicentre controlled randomized trial to demonstrate that volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass).
The results of this study can support the use of volatile agents in all CABG procedures worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be reduced from 3% to 2% using volatile agents).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5400
- age >18 years
- written informed consent
- scheduled procedures
- planned isolated CABG (multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed
- pregnancy
- planned valve surgery or surgery on the aorta
- planned locoregional anesthesia without general anesthesia
- unstable or ongoing angina
- recent (< 1 month) or ongoing acute myocardial infarction
- use of sulfonylurea, theophylline or allopurinol
- previous unusual response to an anesthetic agent
- inclusion in other randomised controlled studies in the previous 30 days
- any general anesthesia performed in the previous 30 days
- emergency operation (not scheduled)
- Kidney or liver transplant in medical history
- Liver cirrhosis (Child B or C)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description volatile anesthetics (desflurane, isoflurane, sevoflurane) desflurane, isoflurane, sevoflurane - total intravenous anesthesia total intravenous anesthetics -
- Primary Outcome Measures
Name Time Method mortality 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Spedali Civili
🇮🇹Brescia, Italy
Humanitas
🇮🇹Milano, Italy
University Hospital Dubrava
🇭🇷Dubrava, Croatia
General University Hospital, Charles University
🇨🇿Prague, Czech Republic, Czechia
Hospital das Clínicas da Faculdade de Medicina da USP - Istituto do Coracao
🇧🇷Sao Paulo, Barazil, Brazil
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Italy
Policlinico San Orsola-Malpighi
🇮🇹Bologna, Italy
Institute for Clinical and Experimental Medicine
🇨🇿Prague, Czech Republic, Czechia
Ospedale San Raffaele di Milano, Italy
🇮🇹Milano, Italy
Federal Almazov Medical Research Centre
🇷🇺Saint Petersburg, Russian Federation
Federal Centre for Cardiac Surgery
🇷🇺Astrakhan, Russian Federation
Policlinico Universitario Magna Graecia
🇮🇹Catanzaro, Italy
Hospital Pulau Pinang
🇲🇾Penang, Malaysia
Azienda Ospedaliera San Camillo-Forlanini
🇮🇹Roma, Italy
Negovskiy Reanimatology Research Institute
🇷🇺Moscow, Russian Federation
Ural Institute of Cardiology
🇷🇺Ekaterinburg, Russian Federation
Mansoura University hospitals
🇪🇬Egypt, Egypt
Faculty of Medicine - Zagazig University
🇪🇬Zagazig, Egypt
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, China
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
AOU Città della Salute e della Scienza
🇮🇹Torino, Italy
Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center - Bahrain
🇧🇭Bahrein, Bahrain
Hospital Serdang
🇲🇾Lumpur, Malaysia
Heart Center Pontica
🇧🇬Burgas, Bulgaria
University Malaya Medical Centre
🇲🇾Lumpur, Malaysia
Sarawak General Hospital
🇲🇾Sarawak, Malaysia
King Abdullah Medical City - KAMC
🇸🇦Mecca, Saudi Arabia
Institute of Cardiovascular Diseases "Dedinje"
🇷🇸Belgrade, Serbia
Dante Pazzanese Institute of Cardiology
🇧🇷Sao Paulo, Brazil
1st Affiliated Hospital of Fourth Military University
🇨🇳Xi'an, China
Wuhan Asia Heart Hospital
🇨🇳Hubei, China
Scientific Research Institute for Complex Issues of Cardiovascular Disease
🇷🇺Kemerovo, Russian Federation
Hospital Santa Maria
🇵🇹Lisbon, Portugal
State Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation
Moscow Clinical Regional Research Institute
🇷🇺Moscow, Russian Federation