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Sympathetic Neural Outflow During Xenon Anesthesia in Humans

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ClinicalTrials.gov Identifier: NCT01043419
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : June 30, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Sympathetic Nervous System Drug: xenon Phase 1

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sympathetic Neural Outflow During Xenon Anesthesia in Humans
Study Start Date : January 2010
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  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 [ Time Frame: In continuous during 30 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043419


Locations
Germany
Department of Anesthesiology; University Hospital of Duesseldorf; Moorenstrasse 5
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Air Liquide Santé International
Investigators
Principal Investigator: Peter KIENBAUM, PD Dr. Department of Anesthesiology, University Hospital Duesseldorf, Moorenstrasse 5, D-40225 Duesseldorf
More Information

Responsible Party: Catherine Billoët, MD, Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01043419     History of Changes
Other Study ID Numbers: ALS-8-09-A-101
Eudract N°2009-012449-48 ( Registry Identifier: Eudract )
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: June 2010

Keywords provided by Air Liquide Santé International:
Xenon Anesthesia
LENOXe™ (xénon 100 % v/v) anesthesia
Muscle Sympathetic Activity
Baroreflex reagibility

Additional relevant MeSH terms:
Anesthetics
Xenon
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General