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

• Sponsor: Heinrich-Heine University, Duesseldorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT02105077
• Collaborator: German Sport University, Cologne (Other)
• Enrollment: 8
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Mar 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Detection of xenon in patient blood sample by mass spectrometry [Immediately before induction of anesthesia]

2. Detection of xenon in patient blood sample by mass spectrometry [During xenon anesthesia]

3. Detection of xenon in patient blood sample by mass spectrometry [4 hours after extubation]

4. Detection of xenon in patient blood sample by mass spectrometry [8 hours after extubation]

5. Detection of xenon in patient blood sample by mass spectrometry [24 hours after xenon anesthesia]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf	Düsseldorf		Germany	40225

Sponsors and Collaborators

• Heinrich-Heine University, Duesseldorf
• German Sport University, Cologne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Klinik für Anästhesiologie, Prof. Dr. Peter Kienbaum, Heinrich-Heine University, Duesseldorf
• ClinicalTrials.gov Identifier: NCT02105077
• Other Study ID Numbers: 2014032273
• First Posted: Apr 7, 2014
• Last Update Posted: Mar 31, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Klinik für Anästhesiologie, Prof. Dr. Peter Kienbaum, Heinrich-Heine University, Duesseldorf: xenon; doping; anesthesia; mass spectrometry; surgery
• Additional relevant MeSH terms: Anesthetics; Xenon

Study Results

No Results Posted as of Mar 31, 2015