Back to resultsEffects of Propofol and Isoflurane on Pulmonary Vascular Resistance
Primary Purpose
Hypertension, Pulmonary
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
propofol and isoflurane
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertension, Pulmonary focused on measuring propofol, isoflurane, pulmonary hypertension, congenital heart disease
Eligibility 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.
Sites / Locations
- UH bristol NHS Trust
Outcomes
Primary Outcome Measures
The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.
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).
Full Information
NCT ID
NCT01212523
First Posted
November 4, 2009
Last Updated
December 14, 2011
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01212523
Brief Title
Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance
Official Title
Randomised Cross-over Pilot Study to Determine the Effects of Isoflurane and Propofol on Pulmonary Vascular Resistance in Children With Pulmonary Hypertension.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
propofol, isoflurane, pulmonary hypertension, congenital heart disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
propofol and isoflurane
Intervention Description
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 Outcome Measure Information:
Title
The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UH bristol NHS Trust
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
12. IPD Sharing Statement
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Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance
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