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| Tracking Information | |||||||||
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| First Received Date † | August 27, 2007 | ||||||||
| Last Updated Date | July 17, 2008 | ||||||||
| Start Date † | January 2005 | ||||||||
| Current Primary Outcome Measures † |
marker expression on blood cells [ Time Frame: December 2008 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00526695 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion | ||||||||
| Official Title † | Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion, Leukocyte/Thrombocyte Activation, and Endothelial Function After Tourniquet-Induced Ischemia/Reperfusion Injury in the Forearm of Volunteers | ||||||||
| Brief Summary | Sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion injury. Study hypothesis: The volatile anesthetic sevoflurane at subanesthetic concentrations achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory markers in the circulation |
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| Detailed Description | Healthy volunteers are included in the study to investigate endothelial function and platelet activation after preconditioning by sevoflurane in subanesthetic concentrations. Forearm perfusion, endothelial function and leukocyte/thrombocyte activation after tourniquet-induced ischemia/reperfusion injury of the forearm are measured using healthy volunteers in a cross-over design. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study | ||||||||
| Condition † | Ischemia/Reperfusion Injury | ||||||||
| Intervention † | Drug: Sevoflurane (Preconditioning) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 10 | ||||||||
| Estimated Completion Date | December 2008 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion criteria: male
Exclusion criteria:
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| Gender | Male | ||||||||
| Ages | 25 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | Switzerland | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00526695 | ||||||||
| Responsible Party | Michael Zaugg, Anesthesiology, Univ. Hospital Zurich | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of Zurich | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of Zurich | ||||||||
| Verification Date | July 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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