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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01091766
First received: March 22, 2010
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Anaesthesia
Toxicity
 Drug: intravenous injection of test solution
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • T-wave elevation in the ECG after intravenous administration of the test solution [ Time Frame: 2 minutes ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 minutes ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 150
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 0 to 16
  • healthy
  • parental consent

Exclusion Criteria:

  • ASA >1
  • allergy against local anaesthetics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091766

Locations
Switzerland
University Children's Hospital, Anesthesiology
Zurich, Switzerland, 8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Markus Weiss, Prof University Childrens Hospital Zurich, Anesthesiology
  More Information

Publications:

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01091766     History of Changes
Other Study ID Numbers: StV 25/09
Study First Received: March 22, 2010
Last Updated: July 23, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Children's Hospital, Zurich:
local anaesthetics toxicity
heart arrhythmia
heart rate
heart conduction
 regional anaesthesia
paediatric anaesthesia
cardio-vascular system
prevention

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013