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

March 30, 2015 updated by: Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
The purpose of this study is to establish a laboratory method to determine from blood samples whether a person has been treated with xenon.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing xenon-based general anesthesia as part of routine care at University Hospital Düsseldorf, Germany

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection of xenon in patient blood sample by mass spectrometry
Time Frame: Immediately before induction of anesthesia
Immediately before induction of anesthesia
Detection of xenon in patient blood sample by mass spectrometry
Time Frame: During xenon anesthesia
During xenon anesthesia
Detection of xenon in patient blood sample by mass spectrometry
Time Frame: 4 hours after extubation
4 hours after extubation
Detection of xenon in patient blood sample by mass spectrometry
Time Frame: 8 hours after extubation
8 hours after extubation
Detection of xenon in patient blood sample by mass spectrometry
Time Frame: 24 hours after xenon anesthesia
24 hours after xenon anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

German Sport University, Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (ESTIMATE)

April 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014032273

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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