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

Primary Purpose

Anaesthesia, Toxicity

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

intravenous injection of test solution

About this trial

This is an interventional prevention trial for Anaesthesia focused on measuring local anaesthetics toxicity, heart arrhythmia, heart rate, heart conduction, regional anaesthesia, paediatric anaesthesia, cardio-vascular system, prevention

Eligibility Criteria

1 Day - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 0 to 16
healthy
parental consent

Exclusion Criteria:

ASA >1
allergy against local anaesthetics

Sites / Locations

University Children's Hospital, Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

bupivacaine

bupivacaine+epinephrine

epinephrine

Arm Description

test solution consists of bupivacaine 0.125%

test solution consists of bupivacaine 0.125% with epinephrine 1:200000

test solution consists of epinephrine 1:200000

Outcomes

Primary Outcome Measures

T-wave elevation in the ECG after intravenous administration of the test solution

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.

Secondary Outcome Measures

Alteration in heart rate caused by intravenous injection of the test solution

Full Information

NCT ID

NCT01091766

First Posted

March 22, 2010

Last Updated

July 23, 2012

Sponsor

University Children's Hospital, Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01091766

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Children's Hospital, Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anaesthesia, Toxicity

Keywords

local anaesthetics toxicity, heart arrhythmia, heart rate, heart conduction, regional anaesthesia, paediatric anaesthesia, cardio-vascular system, prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bupivacaine

Arm Type

Active Comparator

Arm Description

test solution consists of bupivacaine 0.125%

Arm Title

bupivacaine+epinephrine

Arm Type

Active Comparator

Arm Description

test solution consists of bupivacaine 0.125% with epinephrine 1:200000

Arm Title

epinephrine

Arm Type

Active Comparator

Arm Description

test solution consists of epinephrine 1:200000

Intervention Type

Drug

Intervention Name(s)

intravenous injection of test solution

Intervention Description

test dose consists of 0.2 ml/kg body weight test solution of the assigned drug

Intervention Type

Drug

Intervention Name(s)

intravenous injection of test solution

Intervention Description

test dose consists of 0.2 ml/kg body weight test solution of the assigned drug

Intervention Type

Drug

Intervention Name(s)

intravenous injection of test solution

Intervention Description

test dose consists of 0.2 ml/kg body weight test solution of the assigned drug

Primary Outcome Measure Information:

Title

T-wave elevation in the ECG after intravenous administration of the test solution

Description

Time Frame

2 minutes

Secondary Outcome Measure Information:

Title

Alteration in heart rate caused by intravenous injection of the test solution

Description

Time Frame

2 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 0 to 16 healthy parental consent Exclusion Criteria: ASA >1 allergy against local anaesthetics

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus Weiss, Prof

Organizational Affiliation

University Childrens Hospital Zurich, Anesthesiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Children's Hospital, Anesthesiology

City

Zurich

ZIP/Postal Code

8032

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

19915187

Citation

Mauch J, Kutter AP, Madjdpour C, Koepfer N, Frotzler A, Bettschart-Wolfensberger R, Weiss M. Electrocardiographic alterations during intravascular application of three different test doses of bupivacaine and epinephrine: experimental study in neonatal pigs. Br J Anaesth. 2010 Jan;104(1):94-7. doi: 10.1093/bja/aep313.

Results Reference

result

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

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