Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

Phase 4

Completed

• Conditions: Aortocoronary Bypass; Cardiac Surgery; Coronary Artery Bypass Grafting
• Interventions: Drug: desflurane, isoflurane, sevoflurane; 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

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-07
• Study Start: 2014-04-14
• Primary Completion: 2017-10
• Study Completion: 2018-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5400

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Trial Locations

Locations (36)

Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center - Bahrain; 🇧🇭 Bahrein, Bahrain

Hospital das Clínicas da Faculdade de Medicina da USP - Istituto do Coracao; 🇧🇷 Sao Paulo, Barazil, Brazil

Dante Pazzanese Institute of Cardiology; 🇧🇷 Sao Paulo, Brazil

Heart Center Pontica; 🇧🇬 Burgas, Bulgaria

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Wuhan Asia Heart Hospital; 🇨🇳 Hubei, China

1st Affiliated Hospital of Fourth Military University; 🇨🇳 Xi'an, China

University Hospital Dubrava; 🇭🇷 Dubrava, Croatia

General University Hospital, Charles University; 🇨🇿 Prague, Czech Republic, Czechia

Scroll for more (26 remaining)