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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Acidosis

Intervention / Treatment
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* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for heart catheterization under general anesthesia Exclusion Criteria: Participation in another study Preexisting metabolic acidosis Contraindication against Propofol

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath. | Drug: Propofol<br>* Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.<br>* Other names: Disoprivan;|
| No Intervention: Sevoflurane<br>Sevoflurane anesthesia is maintained after obtaining a baseline blood gas analysis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Lactate | Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis. | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Metabolic Acidosis, Pediatric Cardiology, Anesthesia