Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation (PRISCATHLAB)
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.
|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|
- 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.
- 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
|Study Start Date:||June 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Propofol
Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293266
|University Hospital Schleswig-Holstein, Campus Kiel|
|Kiel, Schleswig-Holstein, Germany, 24105|
|Study Director:||Berthold Bein, Prof. Dr.||University Hospital Schleswig-Holstein, Campus Kiel|