The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.
The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anaesthesia for CABG surgery and will therefore necessarily be unblinded to the treatment conditions. Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive xenon for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation
Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation
The feasibility of xenon application compared to sevoflurane application will be assessed by: * The depth of anaesthesia level * The peri-anaesthetic respiratory profile * The peri-anaesthetic haemodynamic profile The following safety parameters will be assessed: * Doses and concentration of study treatments * Trans-esophageal echocardiography * Measures of renal function * Intra-operative blood loss and amount of transfused blood/products * Need for hemodynamic and inotropic support * The patient's regional cerebral tissue oxygenation rSO2 * The incidence of AE and SAE
Time frame: an average of 4 to 6 hours
Secondary efficacy and safety criteria
The following secondary efficacy parameters will be assessed: * the patients organ function status * The severity of postoperative critical illness * The incidence of Post-operative Delirium (POD) * The duration of postoperative intensive care unit and in-hospital stay Secondary safety parameters: * hemodynamic and respiratory profile, including vital signs * incidence of major adverse cardiac and cerebral events (MACCE) * laboratory parameters -post-operative pain * further AE and SAE
Time frame: 6 days
all cause mortality and contentment questioning
Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.
Time frame: 1 year
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