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Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion

Primary Purpose

Ischemia/Reperfusion Injury

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Sevoflurane (Preconditioning)
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia/Reperfusion Injury focused on measuring Ischemia/Reperfusion, Organ Protection, Anesthetics

Eligibility Criteria

25 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion criteria: male

  • Non-smoker
  • No asthma
  • NPO
  • Volunteer

Exclusion criteria:

  • Female
  • Chronic medication
  • Asthma
  • Smoking

Sites / Locations

  • University Hospital of ZurichRecruiting

Outcomes

Primary Outcome Measures

marker expression on blood cells

Secondary Outcome Measures

Full Information

First Posted
August 27, 2007
Last Updated
July 17, 2008
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00526695
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia/Reperfusion Injury
Keywords
Ischemia/Reperfusion, Organ Protection, Anesthetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sevoflurane (Preconditioning)
Intervention Description
Inhalation of sub-anesthetic doses of sevoflurane
Primary Outcome Measure Information:
Title
marker expression on blood cells
Time Frame
December 2008

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: male Non-smoker No asthma NPO Volunteer Exclusion criteria: Female Chronic medication Asthma Smoking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
01 Studienregister MasterAdmins
Phone
+41 (0)44 255 11 11
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zaugg, PD Dr. med.
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Zaugg, PD Dr. med.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Zaugg, MD
Email
michael.zaugg@usz.ch
First Name & Middle Initial & Last Name & Degree
Michael Zaugg, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19762739
Citation
Lucchinetti E, Zeisberger SM, Baruscotti I, Wacker J, Feng J, Zaugg K, Dubey R, Zisch AH, Zaugg M. Stem cell-like human endothelial progenitors show enhanced colony-forming capacity after brief sevoflurane exposure: preconditioning of angiogenic cells by volatile anesthetics. Anesth Analg. 2009 Oct;109(4):1117-26. doi: 10.1213/ANE.0b013e3181b5a277.
Results Reference
derived

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Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion

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