Comparison of measured intravenously administered anesthetics in bloodand in breath - pilot study
Phase 1
- Conditions
- intravenous anaesthesiaTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-004127-36-CZ
- Lead Sponsor
- Podripská nemocnice s poliklinikou, Roudnice n.L., s.r.o
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
ASA 1-2
Age 18-65 years
Patient undergoing intravenous anaesthesia
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Contraindications to intravenous anaesthesia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: pharmacokinetics;Secondary Objective: NA;Primary end point(s): Qualitative and quantitative anaylsis UHPLC-MS/MS;Timepoint(s) of evaluation of this end point: before anaesthesia, 3-5 minutes after dosing, 3-5 minutes after start of surgical intervention, next intervals 10-15 minutes
- Secondary Outcome Measures
Name Time Method Secondary end point(s): other pharmacokinetics parameters;Timepoint(s) of evaluation of this end point: NA