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Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212523
First Posted: September 30, 2010
Last Update Posted: December 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michelle White, University Hospitals Bristol NHS Trust
  Purpose
The investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR).

Condition Intervention Phase
Hypertension, Pulmonary Drug: propofol and isoflurane Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Randomised Cross-over Pilot Study to Determine the Effects of Isoflurane and Propofol on Pulmonary Vascular Resistance in Children With Pulmonary Hypertension.

Resource links provided by NLM:


Further study details as provided by Michelle White, University Hospitals Bristol NHS Trust:

Primary Outcome Measures:
  • The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia. [ Time Frame: 2 hours ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: propofol and isoflurane
    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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212523


Locations
United Kingdom
UH bristol NHS Trust
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
University Hospitals Bristol NHS Foundation Trust
  More Information

Responsible Party: Michelle White, Consultant in Paediatric Anaesthesia and Critical Care, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT01212523     History of Changes
Other Study ID Numbers: CH/2007/2476
2009-010614-30 ( Registry Identifier: EudraCT )
First Submitted: November 4, 2009
First Posted: September 30, 2010
Last Update Posted: December 15, 2011
Last Verified: December 2011

Keywords provided by Michelle White, University Hospitals Bristol NHS Trust:
propofol
isoflurane
pulmonary hypertension
congenital heart disease

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Propofol
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation