Sympathetic Neural Outflow During Xenon Anesthesia in Humans

Air Liquide

Status and phase: Completed; Phase 1

Conditions: Sympathetic Nervous System

Treatments: Drug: xenon

Study type: Interventional

Funder types: Industry

Identifiers

NCT01043419

Eudract N°2009-012449-48 (Registry Identifier)

ALS-8-09-A-101

Details and patient eligibility

About

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.

Full 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

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

LENOXe™ (xénon 100 % v/v)

Experimental group

Description:

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

Treatment:

Drug: xenon