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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

Page last updated: August 20, 2015

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