NCT01293266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
Last Updated

March 11, 2011

Status Verified

February 1, 2011

Enrollment Period

1.2 years

First QC Date

February 9, 2011

Last Update Submit

March 10, 2011

Conditions

Metabolic Acidosis

Keywords

PropofolMetabolic AcidosisPediatric CardiologyAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Serum Lactate

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

    4 hours

Secondary Outcomes (1)

  • pH and base excess

    Hours

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Sevoflurane

NO INTERVENTION

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

Interventions

PropofolDRUG

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

Also known as: Disoprivan
Propofol

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Indication for heart catheterization under general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Acidosis

Interventions

Propofol

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Berthold Bein, Prof. Dr.

    University Hospital Schleswig-Holstein

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

June 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 11, 2011

Record last verified: 2011-02

Locations

DE(1)