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

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01293266
First received: February 9, 2011
Last updated: March 10, 2011
Last verified: February 2011
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 9, 2011
Last Updated: March 10, 2011
Health Authority: Germany: Ethics Commission

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on August 21, 2014