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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014