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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Fabricio T Mendonça, MD contact

5561981882640

correiodofabricio@gmail.com

Brazil1 site, 1 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

    Recruiting

Other trials in Brazil

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 groups in NCT03973411
Study groupRoleWhat they receive
Ondansetron groupActive comparatorPatients will receive intravenous ondansetron before spinal anesthesia
Receives: Drug: Prophylactic ondansetron
Control groupPlacebo comparatorPatients 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.

  1. 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.

  1. First posted4 Jun 2019
  2. Study start1 Mar 2019
  3. Primary completionMar 2020 (estimated)
  4. Study completionMar 2020 (estimated)

Resources

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)
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

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.

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