Effect of Propofol and Sevoflurane on Lactate During Anes... | NCT01293266

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

NCT01293266

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Mar 11, 2011Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Metabolic Acidosis

Interventions

Propofol

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Feb 9, 2011

First Submission Date that Met QC Criteria

Feb 9, 2011

First Posted Date

Feb 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2011

Last Update Posted Date

Mar 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.	Propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum Lactate	Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis.	4 hours

Secondary Outcomes

Measure	Description	Time Frame
pH and base excess	pH and base excess are measured during application of Propofol and Sevoflurane to examine the effect on acid-base balance	Hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for heart catheterization under general anesthesia

Exclusion Criteria:

Participation in another study
Preexisting metabolic acidosis
Contraindication against Propofol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Berthold Bein, Prof. Dr.	University Hospital Schleswig-Holstein	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Schleswig-Holstein, Campus Kiel		Kiel	Schleswig-Holstein	24105	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000138	Acidosis

Ancestor Terms

ID	Term
D000137	Acid-Base Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided