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

Phase 4

Completed

• Conditions: Anaesthesia; Toxicity
• Interventions: Drug: intravenous injection of test solution

• Registration Number: NCT01091766
• Lead Sponsor: University Children's Hospital, Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age 0 to 16
• healthy
• parental consent

Exclusion Criteria

• ASA >1
• allergy against local anaesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine	intravenous injection of test solution	test solution consists of bupivacaine 0.125%
epinephrine	intravenous injection of test solution	test solution consists of epinephrine 1:200000
bupivacaine+epinephrine	intravenous injection of test solution	test solution consists of bupivacaine 0.125% with epinephrine 1:200000

Primary Outcome Measures

Name	Time	Method
T-wave elevation in the ECG after intravenous administration of the test solution	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.

Secondary Outcome Measures

Name	Time	Method
Alteration in heart rate caused by intravenous injection of the test solution	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.

Trial Locations

Locations (1)

University Children's Hospital, Anesthesiology; 🇨🇭 Zurich, Switzerland