RESUMEN
OBJECTIVE: There 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. DESIGN: Single blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio. SETTING: Tertiary and University hospitals. INTERVENTIONS: Patients (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 RESULTS: The 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. CONCLUSIONS: The 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.
Asunto(s)
Anestesia en Procedimientos Quirúrgicos Cardíacos , Anestésicos por Inhalación , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/cirugía , Complicaciones Posoperatorias , Adulto , Anestesia en Procedimientos Quirúrgicos Cardíacos/efectos adversos , Anestesia en Procedimientos Quirúrgicos Cardíacos/métodos , Anestésicos por Inhalación/administración & dosificación , Anestésicos por Inhalación/química , Puente de Arteria Coronaria/efectos adversos , Puente de Arteria Coronaria/métodos , Puente de Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/mortalidad , Femenino , Humanos , Masculino , Evaluación de Procesos y Resultados en Atención de Salud , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Análisis de Supervivencia , VolatilizaciónRESUMEN
Objective: There 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, whethervolatile anesthetics improve the postoperative outcome of cardiac surgical patients remains uncertain. An adequately powered randomized controlled trial appears desirable.Design: Single blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio.Setting: Tertiary and University hospitals.