Sympathetic Neural Outflow During Xenon Anesthesia in Humans

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2010

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

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Air Liquide Santé International
  • Provider of Information About this Clinical Study
    • Catherine Billoët, MD, Air Liquide Santé International
  • Overall Official(s)
    • Peter KIENBAUM, PD Dr., Principal Investigator, Department of Anesthesiology, University Hospital Duesseldorf, Moorenstrasse 5, D-40225 Duesseldorf

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