Sympathetic Neural Outflow During Xenon Anesthesia in Humans

Phase 1

Completed

• Conditions: Sympathetic Nervous System
• Interventions: Drug: xenon

• Registration Number: NCT01043419
• Lead Sponsor: Air Liquide Santé International

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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LENOXe™ (xénon 100 % v/v)	xenon	Influence of LENOXe™ (xénon 100 % v/v) anesthesia on Sympathetic Nervous Activity and Security under LENOXe™ (xénon 100 % v/v) anesthesia

Primary Outcome Measures

Name	Time	Method
Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake	30 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anesthesiology; University Hospital of Duesseldorf; Moorenstrasse 5; 🇩🇪 Duesseldorf, Germany