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

NCT ID: NCT01091766

Last Updated: 2012-07-24

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anaesthesia Toxicity

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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bupivacaine

test solution consists of bupivacaine 0.125%

Group Type ACTIVE_COMPARATOR

intravenous injection of test solution

Intervention Type DRUG

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

bupivacaine+epinephrine

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

Group Type ACTIVE_COMPARATOR

intravenous injection of test solution

Intervention Type DRUG

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

epinephrine

test solution consists of epinephrine 1:200000

Group Type ACTIVE_COMPARATOR

intravenous injection of test solution

Intervention Type DRUG

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

Interventions

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intravenous injection of test solution

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

Intervention Type DRUG

intravenous injection of test solution

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

Intervention Type DRUG

intravenous injection of test solution

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 0 to 16
* healthy
* parental consent

Exclusion Criteria

* ASA \>1
* allergy against local anaesthetics
Minimum Eligible Age

1 Day

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markus Weiss, Prof

Role: PRINCIPAL_INVESTIGATOR

University Childrens Hospital Zurich, Anesthesiology

Locations

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University Children's Hospital, Anesthesiology

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 19915187 (View on PubMed)

Other Identifiers

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StV 25/09

Identifier Type: -

Identifier Source: org_study_id