A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon (CArDiAX)
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.
Coronary Artery Bypass
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study|
- Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation [ Time Frame: an average of 4 to 6 hours ] [ Designated as safety issue: Yes ]
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
- 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.
|Study Start Date:||May 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
Active Comparator: Sevoflurane
Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285271
|Department of Anesthesiology, University Hospital Aachen|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Mark Coburn, PD Dr. med.||Department of Anesthesiology, University Hospital Aachen|