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Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation (PRISCATHLAB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293266
First Posted: February 10, 2011
Last Update Posted: March 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Schleswig-Holstein
  Purpose
Propofol is routinely used for general anesthesia during pediatric heart catheterisation. Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is regarded as an early warning sign of PRIS. In this study the effect of propofol and sevoflurane on serum base excess, pH and lactate are examined during pediatric heart catheterisation.

Condition Intervention
Metabolic Acidosis Drug: Propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effect of Propofol and Sevoflurane on Base Excess, pH and Lactate in Pediatric Heart Catheterisation

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Serum Lactate [ Time Frame: 4 hours ]
    Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis.


Secondary Outcome Measures:
  • pH and base excess [ Time Frame: Hours ]
    pH and base excess are measured during application of Propofol and Sevoflurane to examine the effect on acid-base balance


Enrollment: 40
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol
Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath.
Drug: Propofol
Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.
Other Name: Disoprivan
No Intervention: Sevoflurane
Sevoflurane anesthesia is maintained after obtaining a baseline blood gas analysis.

Detailed Description:
In this prospective randomised study 40 children are anesthetised for pediatric heart catheterisation with propofol (N = 22) or sevoflurane (N = 18) with ethic committee approval. Base excess, pH and lactate were measured by blood gas analysis at the beginning, during and at the end of the procedure. Changes relative to baseline were analysed by paired t-Test with correction for multiple testing. The study was powered to detect a difference of 1.5 mmol/l for base excess and lactate.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for heart catheterization under general anesthesia

Exclusion Criteria:

  • Participation in another study
  • Preexisting metabolic acidosis
  • Contraindication against Propofol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293266


Locations
Germany
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Director: Berthold Bein, Prof. Dr. University Hospital Schleswig-Holstein, Campus Kiel
  More Information

Responsible Party: Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
ClinicalTrials.gov Identifier: NCT01293266     History of Changes
Other Study ID Numbers: Fudickar2
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: March 11, 2011
Last Verified: February 2011

Keywords provided by University of Schleswig-Holstein:
Propofol
Metabolic Acidosis
Pediatric Cardiology
Anesthesia

Additional relevant MeSH terms:
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation