Randomised cross-over pilot study to determine the effects of isoflurane and propofol on pulmonary vascular resistance in children with pulmoanry hypertension - Effect of propofol and isoflurane on pulmonary vascular resistance
- Conditions
- children with pulmonary hypertension
- Registration Number
- EUCTR2009-010614-30-GB
- Lead Sponsor
- niversity Hospitals Bristol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
All children between 3 months and 16 years of age with pulmonary arterial hypertension undergoing a PVR study
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
Children with a known reaction to oneof the study drugs eg malignant hyperpyrexia or a disorder of fatty acid oxidation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: WE hypothesise that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR). Therefore the primary objective of this trial is is to evaluate the equivalaence of the physiological effects of two anaesthetics drugs (propofol and isoflurane) on PVR in children with pulmonary hypertension.;Secondary Objective: To evaluate the physiological effects on systemic vascular resistance;Primary end point(s): Percentage change in PVR under propofol anaesthesia compared with isoflurane anaesthesia
- Secondary Outcome Measures
Name Time Method