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

Metabolic Acidosis Clinical Trial

— PRISCATHLAB  

Official title:

Effect of Propofol and Sevoflurane on Base Excess, pH and Lactate in Pediatric Heart Catheterisation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293266
• Other study ID #: Fudickar2
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: March 10, 2011
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2011
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• Indication for heart catheterization under general anesthesia

Exclusion Criteria:

• Participation in another study

• Preexisting metabolic acidosis

• Contraindication against Propofol

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Acidosis
• Metabolic Acidosis

Intervention

Drug:
• Propofol
Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein, Campus Kiel	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Lactate	Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis.	4 hours	No
Secondary	pH and base excess	pH and base excess are measured during application of Propofol and Sevoflurane to examine the effect on acid-base balance	Hours	No