Clinical Trials Directory

Trials / Completed

CompletedNCT01293266

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
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University Hospital Schleswig-Holstein · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2009-06-01
Primary completion
2010-08-01
Completion
2010-08-01
First posted
2011-02-10
Last updated
2011-03-11

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01293266. Inclusion in this directory is not an endorsement.