Sevoflurane in Cardiac Surgery
Condition: Anesthesia; Cardiac Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be
      randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.

      The investigators want to document whether the cardioprotective properties of volatile agents
      could translate in an improved outcome after cardiac surgery in high risk patients.
    

Detailed description: 
      Background

      It is commonly believed that the choice of the primary anesthetic agent does not result in
      different outcomes after cardiac surgery. Recent evidence however has indicated that volatile
      anesthetics improve post-ischemic recovery. These results have been summarized in a
      meta-analysis of 22 randomized studies, involving 1922 patients: the use of volatile
      anesthetics was associated with significant reductions of myocardial infarctions (24/979
      [2.4%] in the volatile anesthetics group vs 45/874 [5.1%] in the control arm, odds ratio
      [OR]=0.51 [0.32-0.84], and mortality (4/977 [0.4%] vs 14/872 [1.6%], OR=0.31 [0.12-0.80].

      Furthermore, the use of volatile anesthetics was associated with shorter intensive-care unit
      stay (WMD=-7.10 hours [-11.47; -2.73], and time to hospital discharge (WMD=-2.26 days [-3.83;
      -0.68].

      All the studies of the meta-analysis included low risk patients undergoing isolated
      procedures (mostly coronary artery bypass grafting).

      Objectives

      Investigators are planning a large multicentre randomized controlled study to confirm the
      beneficial cardioprotective effects of volatile anesthetics in cardiac surgery as indicated
      by a reduced intensive care stay and/or death in an high risk population of patients
      undergoing combined valvular and coronary procedures. Secondary endpoints will be: cardiac
      troponin release; incidence of myocardial infarction; time on mechanical ventilation;
      postoperative hospital stay

      Methods

      Various centers will randomize 200 patients to receive either a total intravenous anesthesia
      with propofol or an anesthesia with sevoflurane. All patients will receive a standard middle
      dose opiates anesthesia. All the perioperative management will be otherwise identical and
      standardized. Transfer out of the intensive care will be performed with SpO2 94% or greater
      at an FiO2 of 0.5 or less by facemask, adequate cardiac stability with no hemodynamically
      significant arrhythmias, chest tube drainage less than 50 ml/h, urine output greater than 0.5
      ml/kg/h, no intravenous inotropic or vasopressor therapy in excess of dopamine 5 ug/kg/min,
      and no seizure activity.

      Expected Results

      The reduced cardiac damage (reduction in cardiac troponin release and in the incidence of
      myocardial infarction) will translate into a better tissue perfusion and faster recovery as
      documented by reduced intensive care unit.
    

Intervention name(s): sevoflurane; propofol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sevoflurane; Anesthesia; Troponin; Myocardial Preconditioning; Surgery, Cardiac; Stents; Non-cardiac Surgery; Surgery