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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105077
• Other study ID #: 2014032273
• Status: Completed
• Phase: N/A
• First received: March 31, 2014
• Last updated: March 30, 2015
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Anesthesia with inhalative application of xenon gas

Locations

Country	Name	City	State
Germany	Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	German Sport University, Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of xenon in patient blood sample by mass spectrometry		Immediately before induction of anesthesia	No
Primary	Detection of xenon in patient blood sample by mass spectrometry		During xenon anesthesia	No
Primary	Detection of xenon in patient blood sample by mass spectrometry		4 hours after extubation	No
Primary	Detection of xenon in patient blood sample by mass spectrometry		8 hours after extubation	No
Primary	Detection of xenon in patient blood sample by mass spectrometry		24 hours after xenon anesthesia	No