|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
3 June 2013 |
|
Main ID: |
EUCTR2009-012449-48-DE |
|
Date of registration:
|
03/09/2009 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
„Sympathetic neural outflow during Xenon anesthesia in humans“
|
|
Scientific title:
|
„Sympathetic neural outflow during Xenon anesthesia in humans“ |
|
Date of first enrolment:
|
09/11/2009 |
|
Target sample size:
|
8 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012449-48 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: Every subject builts its own control
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
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).
|
|
Intervention(s)
|
Trade Name: Lenox
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: XENON (133 XE)
CAS Number: 14932424
Current Sponsor code: 56582.00.00
Other descriptive name: Lenox
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentration number: 100-
Trade Name: Nipruss
Pharmaceutical Form: Intravenous infusion
CAS Number: 13755-38-9
Other descriptive name: SODIUM NITROPRUSSIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Trade Name: Phenylephrine Hydrochloride
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: PHENYLEPHRINE HYDROCHLORIDE
CAS Number: 61-76-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
|
|
Primary Outcome(s)
|
Secondary Objective: Evaluation of Patients' Safety during Xenon anesthesia
• Baroreflexreagibility
• heart rate
• arterial blood pressure
• aretrial oxygen saturation and CO2 (Pulsoxymetry and transcutanousCO2-evaluation)
• skin impedance
• Plasmakatecholaminconcentration (Noradrenalin, Adrenalin)
• Plasmaangiotensinconcentration
• Plasmareninkonzentration
|
|
Main Objective: Evaluation of Muscular Sympathetic Activity under Xenon Anesthesia
|
|
Primary end point(s): Influence of Xenon anesthesia on sympathetic nerve system
|
|
Secondary ID(s)
|
|
ALS-8-09-A-101
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|