„Sympathetic neural outflow during Xenon anesthesia in humans

Conditions: We would like to frame the thesis, that a general, inhalative Xenon anesthesia (1 MAC) does not effect the sympathetic outflow and the sympathetic baroreflex reagibility under spontaneous breathing. Therefore we intend to monitor and document ECG (heartrate), pulsoximetry (SpO2), transcutanous pO2 and PCO2, invasive blood pressure (A. rad.), microneurographic results (MSA –bursts/minute or burst/100 heart beats) and baroreflexreagibility (MSA/DAP evoked by SNP or Phenylepinephrine).

Registration Number: EUCTR2009-012449-48-DE

Lead Sponsor: Air Liquide Santé International

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 8

Inclusion Criteria

•age >= 18 years and <= 65 years
•legal capacity
•health (ASA I (see Definition under 3.3))
•written consense

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Relevant deseases
Age > 65 or < 18 Jahre
Potential Pregnancyy
Breastfeading females
Non secure contraception
Limited contractual capability
Participation in other clinical trials
Relationship of dependency to sponsor

Contraindications concerning the IMPs:

Pre-known maligna hyperthermia
Increased cranial pressure
Praeecalmpsia or Eclampsia
Pulmonal or Airway Deseases
Risk of higher oxygen supply than normal
Coronary heart disease or heart failure
Aorten isthmic stenosis
Optikusatrophy
Tabakamblyopy
Leck of Vitamin B12
Metabolischer Acidosis
Hypothyreosis
Intrapulmonal arteriovenuous Shunts
Severe hypertension
Ventricular tachycardia
Pheochromocytoma
Intake of viagra® or other virility improving medication during the last 3 months
Pre-known Hyperssensibility concerning the IMPs

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of Muscular Sympathetic Activity under Xenon Anesthesia;Secondary Objective: Evaluation of Patients' Safety during Xenon anesthesia<br>•Baroreflexreagibility<br>•heart rate<br>•arterial blood pressure<br>•aretrial oxygen saturation and CO2 (Pulsoxymetry and transcutanousCO2-evaluation)<br>•skin impedance<br>•Plasmakatecholaminconcentration (Noradrenalin, Adrenalin)<br>•Plasmaangiotensinconcentration<br>•Plasmareninkonzentration<br>;Primary end point(s): Influence of Xenon anesthesia on sympathetic nerve system

Secondary Outcome Measures