NCT02105077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

March 31, 2014

Last Update Submit

March 30, 2015

Conditions

Anesthesia

Keywords

xenondopinganesthesiamass spectrometrysurgery

Outcome Measures

Primary Outcomes (5)

  • Detection of xenon in patient blood sample by mass spectrometry

    Immediately before induction of anesthesia

  • Detection of xenon in patient blood sample by mass spectrometry

    During xenon anesthesia

  • Detection of xenon in patient blood sample by mass spectrometry

    4 hours after extubation

  • Detection of xenon in patient blood sample by mass spectrometry

    8 hours after extubation

  • Detection of xenon in patient blood sample by mass spectrometry

    24 hours after xenon anesthesia

Study Arms (1)

Xenon

Patients undergoing surgery with xenon-based general anesthesia

Drug: Anesthesia with inhalative application of xenon gas

Interventions

Anesthesia with inhalative application of xenon gasDRUG
Xenon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole-blood samples

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Peter Kienbaum

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 7, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

DE(1)