Beta BlockerPhase 4NCT04264286
The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation
A Phase 4 study testing Prophylactic esmolol in people with Beta Blocker and Hemodynamic Instability, run by Hospital de Base at 1 site in Brazil.
Trial summary
Beta-blockers are useful tools for the prevention of hemodynamic instability in the manipulation of airways. The main objective of the present study is to evaluate the effectiveness of using esmolol in attenuating hemodynamic responses at the time of tracheal extubation, by assessing the incidence of tachycardia in… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Beta Blocker, Hemodynamic Instability
- What is being tested?
- Prophylactic esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2019to Jul 2020
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 60 years, electively scaled for surgery requiring general anesthesia.
- Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Who cannot join
- Patients with cardiac disease
- Patients with renal disease
- Patients with liver disease
- Patient with lung disease
- Patients using beta blockers or calcium channel blockers
- Patients who refuse to participate in the study after presenting the informed consent form
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Base do Distrito Federal
Brasília, Federal District, 70335900
Nadja Gloria C Graça, MD, 556133151588, uamphbdf@gmail.com
Viviane Rezende, MD, 556133151331, vrezende@icab.med.br
About this study
Official title: The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation: a Prospective, Randomized, Double-blind and Placebo-controlled Trial
Beta-blockers are useful tools for the prevention of hemodynamic instability in the manipulation of airways. The main objective of the present study is to evaluate the effectiveness of using esmolol in attenuating hemodynamic responses at the time of tracheal extubation, by assessing the incidence of tachycardia in relation to placebo.
Read the detailed description
The moment of extubation represents a critical period of anesthesia where important hemodynamic changes occur. These occur due to stimulation of the larynx, trachea and bronchi that generates an increased release of catecholamines. In high-risk patients, these hemodynamic changes can have serious consequences.
Many strategies have been used to control the hemodynamic response to airway manipulation during the period of intubation, but until today there is no standard therapy for this control during the period of extubation. Therefore, the investigators aim to study the use of beta-blockers in this context.
Beta-blockers are an attractive pharmacological strategy as they reduce the activation of the sympathetic nervous system proper at this time. Esmolol, due to its short half-life, can be an ideal tool to ensure better hemodynamic control.
There are few studies in the literature that study this drug during extubation, and there is no consensus on the best dose or method of administration for this moment.
Therefore, this study aims to evaluate the effectiveness of using esmolol in attenuating hemodynamic responses at the time of tracheal extubation, by assessing the incidence of tachycardia in relation to placebo.
This prospective, randomized, double-blind, placebo-controlled study aims to verify the hypothesis that esmolol reduces hemodynamic instability induced by tracheal extubation in surgical procedures at Base Hospital of the Federal District. The examiners responsible for patient assessment will not have access to the agents used.
Patients will be randomized through a randomly generated list. The examiner responsible for opening the envelope will make the draw, will include the patient in one of the groups, write down their data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the next examiners will not be aware of the administered drug.
Patients will receive standard general anesthesia and after the end of the surgical procedure, patients will be allocated the study drug (esmolol 2 mg/kg) or placebo group. All patients will receive sugammadex as a reversal of neuromuscular block and monitored appropriately.
The evolution of vital signs such as systolic blood pressure, mean heart rate, incidence and intensity of adverse events such as cough, bucking, bradycardia, tachycardia, hypertension, hypotension, vasopressor and anticholinergic consumption will be evaluated.
- Conditions
- Beta Blocker, Hemodynamic Instability
- Being tested
- Prophylactic esmolol, Placebo
- Keywords
- Esmolol, Extubation, Hemodynamic instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic esmololDrug
Patients will receive prophylactic esmolol after the end of the surgery
PlaceboDrug
Patients will prophylactic placebo after the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Esmolol group | Active comparator | Patients will receive intravenous esmolol after the end of the surgical procedure. Receives: Drug: Prophylactic esmolol |
| Placebo group | Placebo comparator | Patients will receive intravenous saline after the end of the surgical procedure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as tachycardia
Intraoperative hemodynamic stability analysis through the incidence tachycardia
Measured: Through study completion, an average of 15 minutes (during awakening from anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jul 2019
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta BlockerStudies 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
- Model description
- Prospective, randomized, double-blind and placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabricio Tavares Mendonca, Hospital de Base
- Investigators
- Fabricio T Mendonça, MD, MSc, Principal investigator, Hospital de Base do Distrito Federal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264286
- Sponsor's protocol ID
- Esmolol and extubation
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation: a Prospective, Randomized, Double-blind and Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04264286
- Acronym / sponsor ID
- Esmolol and extubation
- Conditions
- Beta Blocker, Hemodynamic Instability
- Keywords
- Esmolol, Extubation, Hemodynamic instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 11 Feb 2020 (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.
Beta-blockers are useful tools for the prevention of hemodynamic instability in the manipulation of airways. The main objective of the present study is to evaluate the effectiveness of using esmolol in attenuating hemodynamic responses at the time of tracheal extubation, by assessing the incidence of tachycardia in relation to placebo.
Detailed description
The moment of extubation represents a critical period of anesthesia where important hemodynamic changes occur. These occur due to stimulation of the larynx, trachea and bronchi that generates an increased release of catecholamines. In high-risk patients, these hemodynamic changes can have serious consequences.
Many strategies have been used to control the hemodynamic response to airway manipulation during the period of intubation, but until today there is no standard therapy for this control during the period of extubation. Therefore, the investigators aim to study the use of beta-blockers in this context.
Beta-blockers are an attractive pharmacological strategy as they reduce the activation of the sympathetic nervous system proper at this time. Esmolol, due to its short half-life, can be an ideal tool to ensure better hemodynamic control.
There are few studies in the literature that study this drug during extubation, and there is no consensus on the best dose or method of administration for this moment.
Therefore, this study aims to evaluate the effectiveness of using esmolol in attenuating hemodynamic responses at the time of tracheal extubation, by assessing the incidence of tachycardia in relation to placebo.
This prospective, randomized, double-blind, placebo-controlled study aims to verify the hypothesis that esmolol reduces hemodynamic instability induced by tracheal extubation in surgical procedures at Base Hospital of the Federal District. The examiners responsible for patient assessment will not have access to the agents used.
Patients will be randomized through a randomly generated list. The examiner responsible for opening the envelope will make the draw, will include the patient in one of the groups, write down their data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the next examiners will not be aware of the administered drug.
Patients will receive standard general anesthesia and after the end of the surgical procedure, patients will be allocated the study drug (esmolol 2 mg/kg) or placebo group. All patients will receive sugammadex as a reversal of neuromuscular block and monitored appropriately.
The evolution of vital signs such as systolic blood pressure, mean heart rate, incidence and intensity of adverse events such as cough, bucking, bradycardia, tachycardia, hypertension, hypotension, vasopressor and anticholinergic consumption will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blind and placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Esmolol group | Active comparator | Drug: Prophylactic esmololPatients will receive intravenous esmolol after the end of the surgical procedure. |
| Placebo group | Placebo comparator | Drug: PlaceboPatients will receive intravenous saline after the end of the surgical procedure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 60 years, electively scaled for surgery requiring general anesthesia.
- Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Key exclusion criteria (6 listed)
- Patients with cardiac disease
- Patients with renal disease
- Patients with liver disease
- Patient with lung disease
- Patients using beta blockers or calcium channel blockers
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 |
|---|---|---|
| Prophylactic esmololPatients will receive prophylactic esmolol after the end of the surgery | Drug | Esmolol group |
| PlaceboPatients will prophylactic placebo after the end of the surgery | Drug | Placebo group |
Primary outcome
Number of participants with adverse events as tachycardia
Time frame: Through study completion, an average of 15 minutes (during awakening from anesthesia)
Intraoperative hemodynamic stability analysis through the incidence tachycardia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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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.
Fabricio T Mendonça, MD, MSc principal investigator
Hospital de Base do Distrito Federal
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 Prophylactic esmolol in people with Beta Blocker and Hemodynamic Instability, run by Hospital de Base 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabricio T Mendonça, MD, MSc (5561981882640, correiodofabricio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as tachycardia (time frame: Through study completion, an average of 15 minutes (during awakening from anesthesia)). 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 11 Feb 2020.