BradycardiaPhase 3NCT03065309
Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
A Phase 3 study testing Remifentanil in people with Bradycardia and Hypotension, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bradycardia, Hypotension
- What is being tested?
- Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Feb 2017to 1 Mar 2017
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of anesthesia induction
Who cannot join
- Protocol violation
- Monitoring problems
Trial locations and contacts
1 site in 1 country.
About this study
This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension
Read the detailed description
Remifentanil is becoming popular for rapid sequence intubation because it has a fast onset and ultra-short half-life.
Remifentanil a potent opioid associated to bradycardia and hypotension at high doses.
- Conditions
- Bradycardia, Hypotension
- Being tested
- Remifentanil
- Medical subject headings
- Bradycardia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
bolus dose
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients will receive bolus dose of remifentanil before intubation Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic stability during rapid sequence intubation
no bradycardia and no hypotension
Measured: from anesthesia induction up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start25 Feb 2017
- Primary completion28 Feb 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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 3
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Model description
- Adaptative clinical trial, Dixon's Up-And-Down Method
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
- Investigators
- Gabriel MN Guimarães, MSc, Study director, Head of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065309
- Sponsor's protocol ID
- TCC-Lara-2017
- Status last verified
- Sep 2017
- First submitted
- 22 Feb 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
- ClinicalTrials.gov ID
- NCT03065309
- Acronym / sponsor ID
- TCC-Lara-2017
- Conditions
- Bradycardia, Hypotension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 25 Feb 2017 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 27 Feb 2017 (actual)
- 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.
This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension
Detailed description
Remifentanil is becoming popular for rapid sequence intubation because it has a fast onset and ultra-short half-life.
Remifentanil a potent opioid associated to bradycardia and hypotension at high doses.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adaptative clinical trial, Dixon's Up-And-Down Method
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: RemifentanilPatients will receive bolus dose of remifentanil before intubation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication of anesthesia induction
Key exclusion criteria (2 listed)
- Protocol violation
- Monitoring problems
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 |
|---|---|---|
| Remifentanilbolus dose | Drug | Single Arm |
Primary outcome
hemodynamic stability during rapid sequence intubation
Time frame: from anesthesia induction up to 5 minutes
no bradycardia and no hypotension
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 13 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Gabriel MN Guimarães, MSc study director
Head of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remifentanil in people with Bradycardia and Hypotension, run by Brasilia University Hospital at 1 site in Brazil.
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 1 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 13 Sep 2017. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
hemodynamic stability during rapid sequence intubation (time frame: from anesthesia induction up to 5 minutes). 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 13 Sep 2017.