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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01293266
Other study ID # Fudickar2
Secondary ID
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


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
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