Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation
Information source: University of Schleswig-Holstein
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Acidosis
Intervention: Propofol (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Schleswig-Holstein Official(s) and/or principal investigator(s): Berthold Bein, Prof. Dr., Study Director, Affiliation: University Hospital Schleswig-Holstein, Campus Kiel
Summary
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.
Clinical Details
Official title: Effect of Propofol and Sevoflurane on Base Excess, pH and Lactate in Pediatric Heart Catheterisation
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Primary outcome: Serum Lactate
Secondary outcome: pH and base excess
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
Minimum age: N/A.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Indication for heart catheterization under general anesthesia
Exclusion Criteria:
- Participation in another study
- Preexisting metabolic acidosis
- Contraindication against Propofol
Locations and Contacts
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Schleswig-Holstein 24105, Germany
Additional Information
Starting date: June 2009
Last updated: March 10, 2011
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