Sympathetic Neural Outflow During Xenon Anesthesia in Humans

September 10, 2025 updated by: Air Liquide Santé International
The purpose of this study is to test the hypothesis that sympathetic neural outflow to muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in Healthy Volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives for this study :

  • Main Objective : Influence of Xenon anesthesia on Sympathetic Nervous Activity
  • Secondary Objectives : Security under LENOXe™ (xénon 100 % v/v) anesthesia

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

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
        • Department of Anesthesiology; University Hospital of Duesseldorf; Moorenstrasse 5

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy volunteers > 18 years and < 65 years of age
  • ASA physical status I
  • Legal competence
  • for whom the consent form has been signed

Exclusion Criteria:

  • Healthy volunteers < 18 years and > 65 years of age
  • Pregnancy, lactation period or missing secure anticonvulsive therapy
  • Missing legal competence
  • Participation in other clinical trials
  • Contraindications as mentioned on §4.3 of the SPCs of LENOXe™ (xénon 100 % v/v)
  • Any medication especially of Sildenafil (Viagra®) or other potency remedy
  • Existing relationship of dependency to the sponsor or the investigator

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LENOXe™ (xénon 100 % v/v)
Influence of LENOXe™ (xénon 100 % v/v) anesthesia on Sympathetic Nervous Activity and Security under LENOXe™ (xénon 100 % v/v) anesthesia
Drug: xenon
Inhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial blood pressure, Heart frequency, Arterial O2 and CO2 Saturation,Skin conductance,Concentration of plasma catecholamines, Angiotensin & Renin under Xenon Anesthesia in comparison to awake
Time Frame: In continuous during 30 minutes
In continuous during 30 minutes

Collaborators and Investigators

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

Sponsor

Air Liquide Santé International

Investigators

  • Principal Investigator: Peter KIENBAUM, PD Dr., Department of Anesthesiology, University Hospital Duesseldorf, Moorenstrasse 5, D-40225 Duesseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimated)

January 6, 2010

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALS-8-09-A-101
  • Eudract N°2009-012449-48 (Registry Identifier: Eudract)

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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