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Completed

NCT Number: NCT01212523

Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance

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

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

3 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UH bristol NHS Trust

Bristol, BS2 8BJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol and isoflurane

Drug

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

Primary outcomes

  1. The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.

    Time frame: 2 hours

Secondary outcomes

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

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Other

Registry information

Official study title

Randomised Cross-over Pilot Study to Determine the Effects of Isoflurane and Propofol on Pulmonary Vascular Resistance in Children With Pulmonary Hypertension.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2010
Registry last updated
Dec 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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