Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle White, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT01212523
First received: November 4, 2009
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Hypertension, Pulmonary
Drug: propofol and isoflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Randomised Cross-over Pilot Study to Determine the Effects of Isoflurane and Propofol on Pulmonary Vascular Resistance in Children With Pulmonary Hypertension.

Resource links provided by NLM:


Further study details as provided by University Hospitals Bristol NHS Trust:

Primary Outcome Measures:
  • The primary endpoint is the percentage change in PVR under isoflurane anaesthesia compared with propofol anaesthesia. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

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). [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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
  Eligibility

Ages Eligible for Study:   3 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212523

Locations
United Kingdom
UH bristol NHS Trust
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
University Hospitals Bristol NHS Trust
  More Information

No publications provided

Responsible Party: Michelle White, Consultant in Paediatric Anaesthesia and Critical Care, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT01212523     History of Changes
Other Study ID Numbers: CH/2007/2476, 2009-010614-30
Study First Received: November 4, 2009
Last Updated: December 14, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospitals Bristol NHS Trust:
propofol
isoflurane
pulmonary hypertension
congenital heart disease

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Isoflurane
Propofol
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on April 17, 2014