Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine

July 23, 2012 updated by: University Children's Hospital, Zurich

Sensitivity of Electrocardiogram on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine: a Study in Children of Different Age

The purpose of this prospective randomised study is to investigate electrocardiographic alterations after intravascular injection of three different test solutions of bupivacaine and epinephrine in anaesthetised children up to 16 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • University Children's Hospital, Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 0 to 16
  • healthy
  • parental consent

Exclusion Criteria:

  • ASA >1
  • allergy against local anaesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bupivacaine
test solution consists of bupivacaine 0.125%
Drug: intravenous injection of test solution
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
Active Comparator: bupivacaine+epinephrine
test solution consists of bupivacaine 0.125% with epinephrine 1:200000
Drug: intravenous injection of test solution
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
Active Comparator: epinephrine
test solution consists of epinephrine 1:200000
Drug: intravenous injection of test solution
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T-wave elevation in the ECG after intravenous administration of the test solution
Time Frame: 2 minutes
0.2 ml/kg test solution (bupivacaine or bupivacaine+epinephrine or epinephrine) is intravenously injected. The ECG is recorded over 2 minutes, printed and analysed later on regarding alterations of T-wave.
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alteration in heart rate caused by intravenous injection of the test solution
Time Frame: 2 minutes
0.2 ml/kg test solution (bupivacaine or bupivacaine+epinephrine or epinephrine) is intravenously injected. The ECG is recorded over 2 minutes, printed and analysed later on regarding alterations in heart rate.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Markus Weiss, Prof, University Childrens Hospital Zurich, Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StV 25/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anaesthesia

Clinical Trials on intravenous injection of test solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe