NCT01212523

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 15, 2011

Status Verified

December 1, 2011

Enrollment Period

2.1 years

First QC Date

November 4, 2009

Last Update Submit

December 14, 2011

Conditions

Hypertension, Pulmonary

Keywords

propofolisofluranepulmonary hypertensioncongenital heart disease

Outcome Measures

Primary Outcomes (1)

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

    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).

    2 hours

Interventions

propofol and isofluraneDRUG

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 Criteria

Age3 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH bristol NHS Trust

Bristol, BS2 8BJ, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, PulmonaryHeart Defects, Congenital

Interventions

PropofolIsoflurane

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthers

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Paediatric Anaesthesia and Critical Care

Study Record Dates

First Submitted

November 4, 2009

First Posted

September 30, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 15, 2011

Record last verified: 2011-12

Locations

GB(1)