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Contemp Clin Trials · Aug 2017
Randomized Controlled TrialMortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design.
- Giovanni Landoni, Vladimir Lomivorotov, Antonio Pisano, Nigro Neto Caetano C Anesthesia Section of Cardiothoracic Surgery, Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil., Umberto Benedetto, Biondi Zoccai Giuseppe G Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Department of AngioCardioNeurology, IRCCS, Marco Gemma, Samuele Frassoni, Felice Eugenio Agrò, Massimo Baiocchi, Filomena R Barbosa Gomes Galas, Andrei Bautin, Nikola Bradic, Cristiana Carollo, Giuseppe Crescenzi, Abeer M Elnakera, Mohamed R El-Tahan, Evgeny Fominskiy, Ahmed G Farag, Gordana Gazivoda, Stefano Gianni, Evgeny Grigoryev, Fabio Guarracino, Sidik Hanafi, Weiqing Huang, Gudrun Kunst, Jan Kunstyr, Chong Lei, Rosalba Lembo, Zhi-Jian Li, Valery Likhvantsev, Andrey Lozovskiy, Jun Ma, Fabrizio Monaco, Paolo Navalesi, Bukamal Nazar, Vadim Pasyuga, Elena Porteri, Colin Royse, Laura Ruggeri, Hynek Riha, Fernanda Santos Silva, Luca Severi, Vladimir Shmyrev, Nikolay Uvaliev, Cheng Bin Wang, Chew-Yin Wang, Dario Winterton, Chow-Yen Yong, Jingui Yu, Rinaldo Bellomo, and Alberto Zangrillo.
- Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, Milan 20132, Italy. Electronic address: landoni.giovanni@hsr.it.
- Contemp Clin Trials. 2017 Aug 1; 59: 38-43.
ObjectiveThere is initial evidence that the use of volatile anesthetics can reduce the postoperative release of cardiac troponin I, the need for inotropic support, and the number of patients requiring prolonged hospitalization following coronary artery bypass graft (CABG) surgery. Nevertheless, small randomized controlled trials have failed to demonstrate a survival advantage. Thus, whether volatile anesthetics improve the postoperative outcome of cardiac surgical patients remains uncertain. An adequately powered randomized controlled trial appears desirable.DesignSingle blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio.SettingTertiary and University hospitals.InterventionsPatients (n=10,600) undergoing coronary artery bypass graft will be randomized to receive either volatile anesthetic as part of the anesthetic plan, or total intravenous anesthesia.Measurements And Main ResultsThe primary end point of the study will be one-year mortality (any cause). Secondary endpoints will be 30-day mortality; 30-day death or non-fatal myocardial infarction (composite endpoint); cardiac mortality at 30day and at one year; incidence of hospital re-admission during the one year follow-up period and duration of intensive care unit, and hospital stay. The sample size is based on the hypothesis that volatile anesthetics will reduce 1-year unadjusted mortality from 3% to 2%, using a two-sided alpha error of 0.05, and a power of 0.9.ConclusionsThe trial will determine whether the simple intervention of adding a volatile anesthetic, an intervention that can be implemented by all anesthesiologists, can improve one-year survival in patients undergoing coronary artery bypass graft surgery.Copyright © 2017 Elsevier Inc. All rights reserved.
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