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

NCT ID: NCT01293266

Last Updated: 2011-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Acidosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Sevoflurane

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Disoprivan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Indication for heart catheterization under general anesthesia

Exclusion Criteria

* Participation in another study
* Preexisting metabolic acidosis
* Contraindication against Propofol
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Hospital Schleswig-Holstein, Campus Kiel

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Berthold Bein, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital Schleswig-Holstein

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Fudickar2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Propofol in Emergence Agitation
NCT00535613 COMPLETED PHASE4
Emergence Agitation of Sevoflurane in Pediatric
NCT06830564 COMPLETED PHASE2/PHASE3