Sympathetic Neural Outflow During Xenon Anesthesia in Humans

This study has been completed.
Sponsor:
Information provided by:
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01043419
First received: January 5, 2010
Last updated: June 29, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Sympathetic Nervous System
Drug: xenon
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sympathetic Neural Outflow During Xenon Anesthesia in Humans

Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: xenon

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 5, 2010
Last Updated: June 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on April 14, 2014