AnaesthesiaPhase 4NCT01091766
Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine
A Phase 4 study testing intravenous injection of test solution in people with Anaesthesia and Toxicity, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaesthesia, Toxicity
- What is being tested?
- intravenous injection of test solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 0 to 16
- healthy
- parental consent
Who cannot join
- ASA >1
- allergy against local anaesthetics
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital, Anesthesiology
Zurich, 8032
About this study
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
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.
- Conditions
- Anaesthesia, Toxicity
- Being tested
- intravenous injection of test solution
- Keywords
- local anaesthetics toxicity, heart arrhythmia, heart rate, heart conduction, regional anaesthesia, paediatric anaesthesia, cardio-vascular system, prevention
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous injection of test solutionDrug
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
intravenous injection of test solutionDrug
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
intravenous injection of test solutionDrug
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Active comparator | test solution consists of bupivacaine 0.125% Receives: Drug: intravenous injection of test solution |
| bupivacaine+epinephrine | Active comparator | test solution consists of bupivacaine 0.125% with epinephrine 1:200000 Receives: Drug: intravenous injection of test solution |
| epinephrine | Active comparator | test solution consists of epinephrine 1:200000 Receives: Drug: intravenous injection of test solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-wave elevation in the ECG after intravenous administration of the test solution
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.
Measured: 2 minutes
Secondary outcomes (1)
Alteration in heart rate caused by intravenous injection of the test solution
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Weiss, Prof, Principal investigator, University Childrens Hospital Zurich, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091766
- Sponsor's protocol ID
- StV 25/09
- Status last verified
- Jul 2012
- First submitted
- 22 Mar 2010
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19915187
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01091766
- Acronym / sponsor ID
- StV 25/09
- Conditions
- Anaesthesia, Toxicity
- Keywords
- local anaesthetics toxicity, heart arrhythmia, heart rate, heart conduction, regional anaesthesia, paediatric anaesthesia, cardio-vascular system, prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Active comparator | Drug: intravenous injection of test solutiontest solution consists of bupivacaine 0.125% |
| bupivacaine+epinephrine | Active comparator | Drug: intravenous injection of test solutiontest solution consists of bupivacaine 0.125% with epinephrine 1:200000 |
| epinephrine | Active comparator | Drug: intravenous injection of test solutiontest solution consists of epinephrine 1:200000 |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 0 to 16
- healthy
- parental consent
Key exclusion criteria (2 listed)
- ASA >1
- allergy against local anaesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous injection of test solutiontest dose consists of 0.2 ml/kg body weight test solution of the assigned drug | Drug | bupivacaine |
| intravenous injection of test solutiontest dose consists of 0.2 ml/kg body weight test solution of the assigned drug | Drug | bupivacaine+epinephrine |
| intravenous injection of test solutiontest dose consists of 0.2 ml/kg body weight test solution of the assigned drug | Drug | epinephrine |
Primary outcome
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.
1 secondary outcome
Alteration in heart rate caused by intravenous injection of the test solution
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
- Results publication: PubMed 19915187Mauch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Weiss, Prof principal investigator
University Childrens Hospital Zurich, Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous injection of test solution in people with Anaesthesia and Toxicity, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-wave elevation in the ECG after intravenous administration of the test solution (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.