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

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ClinicalTrials.gov Identifier: NCT01091766
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : July 24, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Anaesthesia Toxicity Drug: intravenous injection of test solution Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2010
Primary Completion Date : July 2011
Study Completion Date : July 2011


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

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:
Pharmaceutical Solutions
Bupivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents