Hypertension, PulmonaryPhase 4NCT01212523
Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance
A Phase 4 study testing propofol and isoflurane in people with Hypertension, Pulmonary, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR). Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- propofol and isoflurane
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children between 3 months and 16 years of age with pulmonary arterial hypertension undergoing a PVR study.
Who cannot join
- Children with a known adverse reaction to one of the study drugs eg malignant hyperpyrexia or a disorder of fatty acid oxidation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Cross-over Pilot Study to Determine the Effects of Isoflurane and Propofol on Pulmonary Vascular Resistance in Children With Pulmonary Hypertension.
The investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR).
- Conditions
- Hypertension, Pulmonary
- Being tested
- propofol and isoflurane
- Keywords
- propofol, isoflurane, pulmonary hypertension, congenital heart disease
- Medical subject headings
- Hypertension, Pulmonary, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.
Measured: 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).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle White, University Hospitals Bristol and Weston NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212523
- Sponsor's protocol ID
- CH/2007/2476
- Other IDs
- 2009-010614-30, 2009
- Status last verified
- Dec 2011
- First submitted
- 4 Nov 2009
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Cross-over Pilot Study to Determine the Effects of Isoflurane and Propofol on Pulmonary Vascular Resistance in Children With Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT01212523
- Acronym / sponsor ID
- CH/2007/2476
- Conditions
- Hypertension, Pulmonary
- Keywords
- propofol, isoflurane, pulmonary hypertension, congenital heart disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between 3 months and 16 years of age with pulmonary arterial hypertension undergoing a PVR study.
Key exclusion criteria (1 listed)
- Children with a known adverse reaction to one of the study drugs eg malignant hyperpyrexia or a disorder of fatty acid oxidation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol and isofluraneboth 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 | Drug | – |
Primary outcome
The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.
Time frame: 2 hours
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol and isoflurane in people with Hypertension, Pulmonary, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2011.