Cardiovascular Response to EpinephrinePhase 4NCT02735018
Comparing Cardiovascular Effects of 1:100,000 and 1:200,000 Epinephrine Solutions
A Phase 4 study testing Epinephrine 1:100,000 and Epinephrine 1:200,000 in people with Cardiovascular Response to Epinephrine, run by Rio de Janeiro State University.
Trial summary
The study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction. Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Response to Epinephrine
- What is being tested?
- Epinephrine 1:100,000 and Epinephrine 1:200,000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Mar 2015
- 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 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class I patients according to the American Society of Anesthesiology (ASA),
- Indication for third molars extraction,
- Similar degree of complexity, according to the classification of Pell and Gregory.
Who cannot join
- Patients with systemic conditions,
- Patients with known allergy to any component of the anesthetic solution.
About this study
Official title: Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations
The study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.
- Conditions
- Cardiovascular Response to Epinephrine
- Being tested
- Epinephrine 1:100,000, Epinephrine 1:200,000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine 1:100,000Drug
Inferior alveolar nerve block with Epinephrine 1:100.000
Epinephrine 1:200,000Drug
Inferior alveolar nerve block with Epinephrine 1:200.000
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine 1:100,000 | Experimental | Inferior alveolar nerve block with Epinephrine 1:100.000 Receives: Drug: Epinephrine 1:100,000 |
| Epinephrine 1:200,000 | Experimental | Inferior alveolar nerve block with Epinephrine 1:200.000 Receives: Drug: Epinephrine 1:200,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: 20 minutes
Blood pressure
Measured: 20 minutes
Arterial oxygen saturation, measured with a pulse oximeter device
Measured: 20 minutes
Bleeding, evaluated by the surgeon as either: 1) normal or 2) excessive
Measured: 20 minutes
Pain, evaluated using a visual analogue scale
Measured: After procedure, about 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Response to EpinephrineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Ritto, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735018
- Sponsor's protocol ID
- 496.117
- Status last verified
- Apr 2016
- First submitted
- 18 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations
- ClinicalTrials.gov ID
- NCT02735018
- Acronym / sponsor ID
- 496.117
- Conditions
- Cardiovascular Response to Epinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Apr 2016 (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 study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine 1:100,000 | Experimental | Drug: Epinephrine 1:100,000Inferior alveolar nerve block with Epinephrine 1:100.000 |
| Epinephrine 1:200,000 | Experimental | Drug: Epinephrine 1:200,000Inferior alveolar nerve block with Epinephrine 1:200.000 |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Class I patients according to the American Society of Anesthesiology (ASA),
- Indication for third molars extraction,
- Similar degree of complexity, according to the classification of Pell and Gregory.
Key exclusion criteria (2 listed)
- Patients with systemic conditions,
- Patients with known allergy to any component of the anesthetic solution.
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 |
|---|---|---|
| Epinephrine 1:100,000Inferior alveolar nerve block with Epinephrine 1:100.000 | Drug | Epinephrine 1:100,000 |
| Epinephrine 1:200,000Inferior alveolar nerve block with Epinephrine 1:200.000 | Drug | Epinephrine 1:200,000 |
Primary outcome
Heart rate
Time frame: 20 minutes
Blood pressure
Time frame: 20 minutes
Arterial oxygen saturation, measured with a pulse oximeter device
Time frame: 20 minutes
Bleeding, evaluated by the surgeon as either: 1) normal or 2) excessive
Time frame: 20 minutes
Pain, evaluated using a visual analogue scale
Time frame: After procedure, about 1 hour
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 12 Apr 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epinephrine 1:100,000 and Epinephrine 1:200,000 in people with Cardiovascular Response to Epinephrine, run by Rio de Janeiro State University.
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 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Heart rate (time frame: 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2016.