A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon
NCT ID: NCT01285271
Last Updated: 2011-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2011-05-31
2011-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Xenon
Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
Xenon
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
Sevoflurane
Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
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
Interventions
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Xenon
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Mark Coburn, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, University Hospital Aachen
Locations
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Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
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References
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Breuer T, Emontzpohl C, Coburn M, Benstoem C, Rossaint R, Marx G, Schalte G, Bernhagen J, Bruells CS, Goetzenich A, Stoppe C. Xenon triggers pro-inflammatory effects and suppresses the anti-inflammatory response compared to sevoflurane in patients undergoing cardiac surgery. Crit Care. 2015 Oct 15;19:365. doi: 10.1186/s13054-015-1082-7.
Stoppe C, Fahlenkamp AV, Rex S, Veeck NC, Gozdowsky SC, Schalte G, Autschbach R, Rossaint R, Coburn M. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study. Br J Anaesth. 2013 Sep;111(3):406-16. doi: 10.1093/bja/aet072. Epub 2013 Apr 11.
Other Identifiers
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2010-023942-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
10-017
Identifier Type: -
Identifier Source: org_study_id