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

RWTH Aachen University

Status and phase: Completed; Phase 3

Conditions: Anesthetics, Inhalation; Coronary Artery Bypass; Sevoflurane; Coronary Disease; Xenon

Treatments: Drug: Xenon; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT01285271

2010-023942-63 (EudraCT Number)

10-017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Xenon

Experimental group

Description:

Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.

Treatment:

Drug: Xenon

Sevoflurane

Active Comparator group

Description:

Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.

Treatment:

Drug: Sevoflurane