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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010614-30-GB
Enrollment
10
Registered
2009-04-16
Start date
2009-05-08
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

children with pulmonary hypertension

Interventions

Trade Name: Propofol Product Name: propofol Pharmaceutical Form: Intravenous infusion Trade Name: Isoflurane Product Name: isoflurane Pharmaceutical Form: Inhalation vapour*

Sponsors

University Hospitals Bristol
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Children with a known reaction to oneof the study drugs eg malignant hyperpyrexia or a disorder of fatty acid oxidation

Design outcomes

Primary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026