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

Not Applicable

Completed

• Conditions: Metabolic Acidosis
• Interventions: Drug: Propofol

• Registration Number: NCT01293266
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief 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.

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-02
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Last Update Submitted: 2011-03-10
• Last Update Posted: 2011-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Indication for heart catheterization under general anesthesia

Exclusion Criteria

• Participation in another study
• Preexisting metabolic acidosis
• Contraindication against Propofol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath.

Primary Outcome Measures

Name	Time	Method
Serum Lactate	4 hours	Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis.

Secondary Outcome Measures

Name	Time	Method
pH and base excess	Hours	pH and base excess are measured during application of Propofol and Sevoflurane to examine the effect on acid-base balance

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany