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Completed

NCT Number: NCT01293266

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

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.

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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for heart catheterization under general anesthesia

Exclusion criteria

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

Treatment and study plan

Propofol

Drug

Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.

Other names: Disoprivan

Primary outcomes

  1. Serum Lactate

    Time frame: 4 hours

    Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis.

Secondary outcomes

  1. pH and base excess

    Time frame: Hours

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

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Acronym: PRISCATHLAB

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2011
Registry last updated
Mar 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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