Sympathetic Neural Outflow During Xenon Anesthesia in Humans

Sympathetic Nervous System Clinical Trial

Official title:

Sympathetic Neural Outflow During Xenon Anesthesia in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043419
• Other study ID #: ALS-8-09-A-101
• Secondary ID: Eudract N°2009-0
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2010
• Last updated: June 29, 2010
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: June 2010
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sympathetic Nervous System

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology; University Hospital of Duesseldorf; Moorenstrasse 5	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide Santé International

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake		30 minutes	No
Secondary	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		In continuous during 30 minutes	Yes