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
| Type | Name | Description |
|---|---|---|
| DRUG | Propofol | Anesthesia 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.