HypotensionPhase 4NCT03973411
Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia
A Phase 4 study testing Prophylactic ondansetron in people with Hypotension, run by Hospital de Base at 1 site in Brazil.
Trial summary
Ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic. The main objective of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension
- What is being tested?
- Prophylactic ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to Mar 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 70 years, electively scaled for surgery requiring neuraxial block, with programming of spinal anesthesia.
- Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Who cannot join
- Patients taking prophylactic or therapeutic anticoagulation, except respecting the allowed range;
- Patients with atrioventricular block
- Patients with cardiac arrhythmias
- Patients with heart failure;
- Patients with renal disease
- Patients with liver disease
- Patient carrying or suspecting any type of systemic infection or located in a puncture site;
- Patients who refuse to participate in the study after presenting the free and 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, 70680250
Jamil Elias, MD, 556133151588, uamphbdf@gmail.com
Viviane Rezende, MD, 556133151331, vrezende@icab.med.br
About this study
Official title: Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic. The main objective of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension
Read the detailed description
Spinal anesthesia is usually the first choice for many surgical procedures of lower limbs, perineum, and lower abdomen. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia.
Hypotension results mainly from a decrease in systemic vascular resistance secondary to a blockage of sympathetic fibers. The Bezold-Jarisch reflex, proposed as a mechanism for bradycardia is mediated by serotonin receptors (subtype 5-HT3) located in the vagus nerve and within the walls of the cardiac ventricles. 5-HT3 receptors are activated in response to systemic hypotension, causing increased vagal efferent signaling, bradycardia, reduced cardiac output and increased exacerbation of hypotension.
Therefore, ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic, is potentially useful in attenuating this response. To assess this response, the main goal of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension.
This prospective, randomized, double-blind, placebo-controlled study aims to verify the hypothesis that blocking serotonin type 3 receptors with intravenous ondansetron prior to subarachnoid block reduces hypotension induced by spinal anesthesia 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 monitoring, venoclysis, intravenous midazolam as pre-anesthetic medication. The study drug (ondansetron 0.15 mg / kg or placebo) will then be administered. All patients received spinal anesthesia with hyperbaric bupivacaine and opioid adjuvants at the discretion of the anesthesiologist.
The evolution of vital signs such as systolic blood pressure, mean heart rate, height of the sensitive block, incidence of adverse events such as bradycardia, tachycardia, hypertension or hypotension, nausea, vomiting, vasopressor and antiemetic consumption will be evaluated.
- Conditions
- Hypotension
- Being tested
- Prophylactic ondansetron, Placebo
- Keywords
- Ondansetron, Hypotension, Spinal anesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic ondansetronDrug
Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia
PlaceboDrug
Pacients will receibe standard spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron group | Active comparator | Patients will receive intravenous ondansetron before spinal anesthesia Receives: Drug: Prophylactic ondansetron |
| Control group | Placebo comparator | Patients will receive intravenous saline before spinal anesthesia 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 hypotension
Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Mar 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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, duble-blind and placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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, Principal investigator, Hospital de Base do Distrito Federal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973411
- Sponsor's protocol ID
- Ondansetron for spinal
- Status last verified
- Jun 2019
- First submitted
- 29 May 2019
- Last updated
- 4 Jun 2019
- 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 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03973411
- Acronym / sponsor ID
- Ondansetron for spinal
- Conditions
- Hypotension
- Keywords
- Ondansetron, Hypotension, Spinal anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 4 Jun 2019 (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.
Ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic. The main objective of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension
Detailed description
Spinal anesthesia is usually the first choice for many surgical procedures of lower limbs, perineum, and lower abdomen. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia.
Hypotension results mainly from a decrease in systemic vascular resistance secondary to a blockage of sympathetic fibers. The Bezold-Jarisch reflex, proposed as a mechanism for bradycardia is mediated by serotonin receptors (subtype 5-HT3) located in the vagus nerve and within the walls of the cardiac ventricles. 5-HT3 receptors are activated in response to systemic hypotension, causing increased vagal efferent signaling, bradycardia, reduced cardiac output and increased exacerbation of hypotension.
Therefore, ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic, is potentially useful in attenuating this response. To assess this response, the main goal of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension.
This prospective, randomized, double-blind, placebo-controlled study aims to verify the hypothesis that blocking serotonin type 3 receptors with intravenous ondansetron prior to subarachnoid block reduces hypotension induced by spinal anesthesia 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 monitoring, venoclysis, intravenous midazolam as pre-anesthetic medication. The study drug (ondansetron 0.15 mg / kg or placebo) will then be administered. All patients received spinal anesthesia with hyperbaric bupivacaine and opioid adjuvants at the discretion of the anesthesiologist.
The evolution of vital signs such as systolic blood pressure, mean heart rate, height of the sensitive block, incidence of adverse events such as bradycardia, tachycardia, hypertension or hypotension, nausea, vomiting, vasopressor and antiemetic 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, duble-blind and placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ondansetron group | Active comparator | Drug: Prophylactic ondansetronPatients will receive intravenous ondansetron before spinal anesthesia |
| Control group | Placebo comparator | Drug: PlaceboPatients will receive intravenous saline before spinal anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 70 years, electively scaled for surgery requiring neuraxial block, with programming of spinal anesthesia.
- Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Key exclusion criteria (8 listed)
- Patients taking prophylactic or therapeutic anticoagulation, except respecting the allowed range;
- Patients with atrioventricular block
- Patients with cardiac arrhythmias
- Patients with heart failure;
- Patients with renal disease
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 ondansetronPacients will receibe prophylactic ondansetron plus standard spinal anesthesia | Drug | Ondansetron group |
| PlaceboPacients will receibe standard spinal anesthesia | Drug | Control group |
Primary outcome
Number of participants with adverse events as hypotension
Time frame: During surgery
Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
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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 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 ondansetron in people with Hypotension, 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 8 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 4 Jun 2019. 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 (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 hypotension (time frame: During surgery). 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 4 Jun 2019.