AnesthesiaNCT02105077
Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans
An observational study of Anesthesia, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Anesthesia with inhalative application of xenon gas
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing xenon-based general anesthesia as part of routine care at University Hospital Düsseldorf, Germany
Who may be able to join
- Age of 18 years and older
- Xenon-based anesthesia as part of routine care
Who cannot join
- Inability to give written informed consent
- Known pregnancy
- Hemoglobin concentration of less than 12g/dl
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf
Düsseldorf, 40225
About this study
The purpose of this study is to establish a laboratory method to determine from blood samples whether a person has been treated with xenon.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Anesthesia with inhalative application of xenon gas
- Keywords
- xenon, doping, anesthesia, mass spectrometry, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia with inhalative application of xenon gasDrug
| Study group | Role | What they receive |
|---|---|---|
| Xenon | Patients undergoing surgery with xenon-based general anesthesia Receives: Drug: Anesthesia with inhalative application of xenon gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of xenon in patient blood sample by mass spectrometry
Measured: Immediately before induction of anesthesia
Detection of xenon in patient blood sample by mass spectrometry
Measured: During xenon anesthesia
Detection of xenon in patient blood sample by mass spectrometry
Measured: 4 hours after extubation
Detection of xenon in patient blood sample by mass spectrometry
Measured: 8 hours after extubation
Detection of xenon in patient blood sample by mass spectrometry
Measured: 24 hours after xenon anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Sport University, Cologne
- Responsible party
- Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105077
- Sponsor's protocol ID
- 2014032273
- Status last verified
- Mar 2015
- First submitted
- 31 Mar 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans
- ClinicalTrials.gov ID
- NCT02105077
- Acronym / sponsor ID
- 2014032273
- Conditions
- Anesthesia
- Keywords
- xenon, doping, anesthesia, mass spectrometry, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- German Sport University, Cologne
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish a laboratory method to determine from blood samples whether a person has been treated with xenon.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xenon | – | Drug: Anesthesia with inhalative application of xenon gasPatients undergoing surgery with xenon-based general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing xenon-based general anesthesia as part of routine care at University Hospital Düsseldorf, Germany
Key inclusion criteria (2 listed)
- Age of 18 years and older
- Xenon-based anesthesia as part of routine care
Key exclusion criteria (3 listed)
- Inability to give written informed consent
- Known pregnancy
- Hemoglobin concentration of less than 12g/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia with inhalative application of xenon gas | Drug | Xenon |
Primary outcome
Detection of xenon in patient blood sample by mass spectrometry
Time frame: Immediately before induction of anesthesia
Detection of xenon in patient blood sample by mass spectrometry
Time frame: During xenon anesthesia
Detection of xenon in patient blood sample by mass spectrometry
Time frame: 4 hours after extubation
Detection of xenon in patient blood sample by mass spectrometry
Time frame: 8 hours after extubation
Detection of xenon in patient blood sample by mass spectrometry
Time frame: 24 hours after xenon anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of xenon in patient blood sample by mass spectrometry (time frame: Immediately before induction of anesthesia). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015; AzTrials last refreshed its copy on 1 Nov 2026.