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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01293266

Acronym

PRISCATHLAB

Enrollment

Registered

2011-02-10

Start date

2009-06-30

Completion date

2010-08-31

Last updated

2011-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Acidosis

Keywords

Propofol, Metabolic Acidosis, Pediatric Cardiology, Anesthesia

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.

Interventions

DRUGPropofol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Years

Healthy volunteers

Inclusion criteria

* Indication for heart catheterization under general anesthesia

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026