Sympathetic Neural Outflow During Xenon Anesthesia in Humans
2 other identifiers
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedSeptember 11, 2025
September 1, 2025
2 months
January 5, 2010
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake
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
In continuous during 30 minutes
Study Arms (1)
LENOXe™ (xénon 100 % v/v)
EXPERIMENTALInfluence of LENOXe™ (xénon 100 % v/v) anesthesia on Sympathetic Nervous Activity and Security under LENOXe™ (xénon 100 % v/v) anesthesia
Interventions
Inhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes
Eligibility Criteria
You may qualify if:
- Healthy volunteers \> 18 years and \< 65 years of age
- ASA physical status I
- Legal competence
- for whom the consent form has been signed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology; University Hospital of Duesseldorf; Moorenstrasse 5
Düsseldorf, 40225, Germany
Related Publications (1)
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.
PMID: 22945969BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter KIENBAUM, PD Dr.
Department of Anesthesiology, University Hospital Duesseldorf, Moorenstrasse 5, D-40225 Duesseldorf
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 6, 2010
Study Start
January 1, 2010
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
September 11, 2025
Record last verified: 2025-09