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Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02105077
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : March 31, 2015
Sponsor:
Collaborator:
German Sport University, Cologne
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf

Brief Summary:
The purpose of this study is to establish a laboratory method to determine from blood samples whether a person has been treated with xenon.

Condition or disease Intervention/treatment
Anesthesia Drug: Anesthesia with inhalative application of xenon gas

Detailed Description:

The noble gas xenon is used for general anesthesia in clinical routine. Recent reports indicate that xenon is also used for increasing performance in high-performance sports. The purpose of this study is to establish a method for detecting xenon exposure in humans.

In patients undergoing surgery with xenon anesthesia as part of routine hospital care, small blood samples (3ml) will be taken before anesthesia, during anaesthesia and at 1,2, 4, 8, 16, 24, 32, 40 and 48 hours after anesthesia. These blood samples will be analyzed for traces of xenon.

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Group/Cohort Intervention/treatment
Xenon
Patients undergoing surgery with xenon-based general anesthesia
Drug: Anesthesia with inhalative application of xenon gas



Primary Outcome Measures :
  1. Detection of xenon in patient blood sample by mass spectrometry [ Time Frame: Immediately before induction of anesthesia ]
  2. Detection of xenon in patient blood sample by mass spectrometry [ Time Frame: During xenon anesthesia ]
  3. Detection of xenon in patient blood sample by mass spectrometry [ Time Frame: 4 hours after extubation ]
  4. Detection of xenon in patient blood sample by mass spectrometry [ Time Frame: 8 hours after extubation ]
  5. Detection of xenon in patient blood sample by mass spectrometry [ Time Frame: 24 hours after xenon anesthesia ]

Biospecimen Retention:   Samples With DNA
Whole-blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing xenon-based general anesthesia as part of routine care at University Hospital Düsseldorf, Germany
Criteria

Inclusion Criteria:

  • Age of 18 years and older
  • Xenon-based anesthesia as part of routine care

Exclusion Criteria:

  • Inability to give written informed consent
  • Known pregnancy
  • Hemoglobin concentration of less than 12g/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105077


Locations
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Germany
Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
German Sport University, Cologne

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Responsible Party: Klinik für Anästhesiologie, Prof. Dr. Peter Kienbaum, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02105077    
Other Study ID Numbers: 2014032273
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf:
xenon
doping
anesthesia
mass spectrometry
surgery
Additional relevant MeSH terms:
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Anesthetics
Xenon
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General