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NCT Number: NCT02105610

Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center - Bahrain, Bahrein, Bahrain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

desflurane, isoflurane, sevoflurane

Drug

total intravenous anesthetics

Drug

Primary outcomes

  1. mortality

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

Volatile Anesthetics to Reduce Mortality in Cardiac Surgery: A Multicentre Randomized Controlled Study

Acronym: MYRIAD

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Apr 7, 2014
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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