Effects of Sevoflurane in Subanesthetic Concentrations on... | NCT00526695

Studies
Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion

NCT00526695

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Jul 18, 2008Estimated

Enrollment

10Estimated

Phase

Phase 4

Conditions

Ischemia/Reperfusion Injury

Interventions

Sevoflurane (Preconditioning)

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Aug 27, 2007

First Submission Date that Met QC Criteria

Sep 6, 2007

First Posted Date

Sep 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2008

Last Update Posted Date

Jul 18, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane (Preconditioning)	Drug	Inhalation of sub-anesthetic doses of sevoflurane

Measure	Description	Time Frame
marker expression on blood cells		December 2008

Eligibility Module

Eligibility Criteria

Inclusion criteria: male

Non-smoker
No asthma
NPO
Volunteer

Exclusion criteria:

Female
Chronic medication
Asthma
Smoking

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
01 Studienregister MasterAdmins	Contact	+41 (0)44 255 11 11

Overall Officials

Name	Affiliation	Role
Michael Zaugg, PD Dr. med.	UniversitaetsSpital Zuerich	Principal Investigator
Michael Zaugg, PD Dr. med.	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Zurich	Recruiting	Zurich			Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19762739	Derived	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

ID	Term
D015427	Reperfusion Injury
D007511	Ischemia