Effects of Propofol and Isoflurane on Pulmonary Vascular... | NCT01212523

Studies
Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance

NCT01212523

Sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Status

Completed

Last Update Posted

Dec 15, 2011Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Hypertension, Pulmonary

Interventions

propofol and isoflurane

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-010614-30	Registry Identifier	EudraCT

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Nov 4, 2009

First Submission Date that Met QC Criteria

Sep 29, 2010

First Posted Date

Sep 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2011

Last Update Posted Date

Dec 15, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michelle White, Consultant in Paediatric Anaesthesia and Critical Care, University Hospitals Bristol and Weston NHS Foundation TrustPrincipal Investigator

Lead Sponsor

University Hospitals Bristol and Weston NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propofol and isoflurane	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia.		2 hours

Secondary Outcomes

Measure	Description	Time Frame
The secondary endpoints are the percentage change in mean pulomanry artery pressure (PAP), systemic vascular resistance (SVR) and mean arterial pressure (MAP).		2 hours

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH bristol NHS Trust		Bristol		BS2 8BJ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D007530	Isoflurane

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided