Sympathetic Neural Outflow During Xenon Anesthesia in Humans

NCT ID: NCT01043419

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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

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Sympathetic Nervous System

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

xenon

Intervention Type DRUG

Inhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes

Interventions

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xenon

Inhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Liquide Santé International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter KIENBAUM, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Hospital Duesseldorf, Moorenstrasse 5, D-40225 Duesseldorf

Locations

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Department of Anesthesiology; University Hospital of Duesseldorf; Moorenstrasse 5

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 22945969 (View on PubMed)

Other Identifiers

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Eudract N°2009-012449-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

ALS-8-09-A-101

Identifier Type: -

Identifier Source: org_study_id

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