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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023942-63 | EudraCT Number |
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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenon | Experimental | Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation. |
|
| Sevoflurane | Active Comparator | Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 following safety parameters will be assessed:
| an average of 4 to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy and safety criteria | The following secondary efficacy parameters will be assessed:
Secondary safety parameters:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Coburn, PD Dr. med. | Department of Anesthesiology, University Hospital Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, University Hospital Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26467531 | Derived | 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. | |
| 23578862 |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D008738 |
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| Sevoflurane | Drug | inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation |
|
| 6 days |
| 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 |
| 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. |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |