Sympathetic Nervous SystemPhase 1NCT01043419
Sympathetic Neural Outflow During Xenon Anesthesia in Humans
A Phase 1 study testing xenon in people with Sympathetic Nervous System, run by Air Liquide Santé International at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sympathetic Nervous System
- What is being tested?
- xenon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Mar 2010
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy volunteers > 18 years and < 65 years of age
- ASA physical status I
- Legal competence
- for whom the consent form has been signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology; University Hospital of Duesseldorf; Moorenstrasse 5
Düsseldorf, 40225
About this study
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.
Read the 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
- Conditions
- Sympathetic Nervous System
- Being tested
- xenon
- Keywords
- Xenon Anesthesia, LENOXe™ (xénon 100 % v/v) anesthesia, Muscle Sympathetic Activity, Baroreflex reagibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xenonDrug
Inhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| LENOXe™ (xénon 100 % v/v) | Experimental | Influence of LENOXe™ (xénon 100 % v/v) anesthesia on Sympathetic Nervous Activity and Security under LENOXe™ (xénon 100 % v/v) anesthesia Receives: Drug: xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake
Measured: 30 minutes
Secondary outcomes (1)
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
Measured: In continuous during 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sympathetic Nervous SystemStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter KIENBAUM, PD Dr., Principal investigator, Department of Anesthesiology, University Hospital Duesseldorf, Moorenstrasse 5, D-40225 Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043419
- Sponsor's protocol ID
- ALS-8-09-A-101
- Other IDs
- Eudract N°2009-012449-48
- Status last verified
- Sep 2025
- First submitted
- 5 Jan 2010
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Neukirchen M, Hipp J, Schaefer MS, Brandenburger T, Bauer I, Winterhalter M, Kienbaum P, Werdehausen R. Cardiovascular stability and unchanged muscle sympathetic activity during xenon anaesthesia: role of norepinephrine uptake inhibition. Br J Anaesth. 2012 Dec;109(6):887-96. doi: 10.1093/bja/aes303. Epub 2012 Sep 3.
PubMed 22945969
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Neural Outflow During Xenon Anesthesia in Humans
- ClinicalTrials.gov ID
- NCT01043419
- Acronym / sponsor ID
- ALS-8-09-A-101
- Conditions
- Sympathetic Nervous System
- Keywords
- Xenon Anesthesia, LENOXe™ (xénon 100 % v/v) anesthesia, Muscle Sympathetic Activity, Baroreflex reagibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Jan 2010 (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 test the hypothesis that sympathetic neural outflow to muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in Healthy Volunteers.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LENOXe™ (xénon 100 % v/v) | Experimental | Drug: xenonInfluence of LENOXe™ (xénon 100 % v/v) anesthesia on Sympathetic Nervous Activity and Security under LENOXe™ (xénon 100 % v/v) anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers > 18 years and < 65 years of age
- ASA physical status I
- Legal competence
- for whom the consent form has been signed
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| xenonInhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes | Drug | LENOXe™ (xénon 100 % v/v) |
Primary outcome
Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake
Time frame: 30 minutes
1 secondary outcome
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
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 11 Sep 2025.
- Results publication: PubMed 22945969Neukirchen M, Hipp J, Schaefer MS, Brandenburger T, Bauer I, Winterhalter M, Kienbaum P, Werdehausen R. Cardiovascular stability and unchanged muscle sympathetic activity during xenon anaesthesia: role of norepinephrine uptake inhibition. Br J Anaesth. 2012 Dec;109(6):887-96. doi: 10.1093/bja/aes303. Epub 2012 Sep 3.
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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.
Peter KIENBAUM, PD Dr. principal investigator
Department of Anesthesiology, University Hospital Duesseldorf, Moorenstrasse 5, D-40225 Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing xenon in people with Sympathetic Nervous System, run by Air Liquide Santé International 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 4 inclusion and 7 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 11 Sep 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01043419, which also lists 1 linked publication.
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 11 Sep 2025.