Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-27 @ 8:56 AM
Study NCT ID:
NCT01293266
Status:
COMPLETED
Last Update Posted:
2011-03-11
First Post:
2011-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation
Sponsor:
University Hospital Schleswig-Holstein
Organization:
Study Overview
Official Title:
Effect of Propofol and Sevoflurane on Base Excess, pH and Lactate in Pediatric Heart Catheterisation
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISCATHLAB
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: