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Effects 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 Pulmonary Hypertension.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01212523
Enrollment
10
Registered
2010-09-30
Start date
2009-11-30
Completion date
2011-12-31
Last updated
2011-12-15

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

Conditions

Hypertension, Pulmonary

Keywords

propofol, isoflurane, pulmonary hypertension, congenital heart disease

Brief summary

The investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR).

Interventions

both drugs administered at age-related dose and titrated to effect. maximum dose of propofol 15 mg/kg/hr, maximum dose of isoflurane 1.5 MAC

Sponsors

University Hospitals Bristol and Weston NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Months to 16 Years
Healthy volunteers
No

Inclusion criteria

* All children between 3 months and 16 years of age with pulmonary arterial hypertension undergoing a PVR study.

Exclusion criteria

* Children with a known adverse reaction to one of the study drugs eg malignant hyperpyrexia or a disorder of fatty acid oxidation.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.2 hours

Secondary

MeasureTime frame
The secondary endpoints are the percentage change in mean pulomanry artery pressure (PAP), systemic vascular resistance (SVR) and mean arterial pressure (MAP).2 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026