A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon (CArDiAX)

• Secondary efficacy and safety criteria [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

  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
• all cause mortality and contentment questioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.

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.

• Xenon
• Sevoflurane
• Anesthetics, Inhalation
• Coronary Disease
• Coronary Artery Bypass

• Drug: Xenon
  gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
• Drug: Sevoflurane
  inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation

• Experimental: Xenon
  Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
  Intervention: Drug: Xenon
• Active Comparator: Sevoflurane
  Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
  Intervention: Drug: Sevoflurane

Inclusion Criteria:

• Patients with coronary artery disease scheduled for elective CABG
• Patients willing and able to complete the requirements of this study
• Ejection Fraction > 50%
• EuroSCORE ≤ 8
• men and women >= 50 yrs
• women without childbearing potential
• ASA Score II-IV

Exclusion Criteria:

• Lack of informed consent
• EuroSCORE < 8
• MMSE < 24
• Age < 50 years
• COPD GOLD > II, increased need of oxygen
• Renal dysfunction
• Liver function disorders
• Acute coronary syndrome during the last 24 hours; hemodynamic instability
• Requirement of inotropic support
• Off-pump-surgery
• Disabling neuropsychiatric disorders
• History of stroke with residuals
• Hypersensitivity to the study anaesthetics
• Increased intracranial pressure
• Pregnancy and lactation period
• Women of childbearing potential
• Presumed uncooperativeness or legal incapacity
• Participation in a concomitant trial