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

Primary Purpose

Metabolic Acidosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Propofol
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Metabolic Acidosis focused on measuring Propofol, Metabolic Acidosis, Pediatric Cardiology, Anesthesia

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for heart catheterization under general anesthesia

Exclusion Criteria:

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

Sites / Locations

  • University Hospital Schleswig-Holstein, Campus Kiel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Propofol

Sevoflurane

Arm Description

Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath.

Sevoflurane anesthesia is maintained after obtaining a baseline blood gas analysis.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 9, 2011
Last Updated
March 10, 2011
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT01293266
Brief Title
Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation
Acronym
PRISCATHLAB
Official Title
Effect of Propofol and Sevoflurane on Base Excess, pH and Lactate in Pediatric Heart Catheterisation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis
Keywords
Propofol, Metabolic Acidosis, Pediatric Cardiology, Anesthesia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath.
Arm Title
Sevoflurane
Arm Type
No Intervention
Arm Description
Sevoflurane anesthesia is maintained after obtaining a baseline blood gas analysis.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Disoprivan
Intervention Description
Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.
Primary Outcome Measure Information:
Title
Serum Lactate
Description
Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
pH and base excess
Description
pH and base excess are measured during application of Propofol and Sevoflurane to examine the effect on acid-base balance
Time Frame
Hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for heart catheterization under general anesthesia Exclusion Criteria: Participation in another study Preexisting metabolic acidosis Contraindication against Propofol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Bein, Prof. Dr.
Organizational Affiliation
University Hospital Schleswig-Holstein, Campus Kiel
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

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

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