Coronary Disease Clinical Trial
— CArDiAXOfficial title:
The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology, University Hospital Aachen | Aachen | NRW |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University | German Research Foundation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
an average of 4 to 6 hours | Yes |
Secondary | 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 |
6 days | Yes |
Secondary | all cause mortality and contentment questioning | Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination. | 1 year | No |
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