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Completed

NCT Number: NCT01091766

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

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.

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Key information

Conditions

Anaesthesia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Toxicity

Age range

1 day–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Children's Hospital, Anesthesiology

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 0 to 16
  • healthy
  • parental consent

Exclusion criteria

  • ASA >1
  • allergy against local anaesthetics

Treatment and study plan

intravenous injection of test solution

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2010
Registry last updated
Jul 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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