Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance

NCT ID: NCT01212523

Last Updated: 2011-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hypertension, Pulmonary

Keywords

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propofol isoflurane pulmonary hypertension congenital heart disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Michelle White

Consultant in Paediatric Anaesthesia and Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UH bristol NHS Trust

Bristol, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2009-010614-30

Identifier Type: REGISTRY

Identifier Source: secondary_id

CH/2007/2476

Identifier Type: -

Identifier Source: org_study_id