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Status unknownNCT03973411Updated Jun 4, 2019

Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia

A Phase 4 interventional study of Prophylactic ondansetron and Placebo in Hypotension, sponsored by Hospital de Base. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-04.

Sponsored by Hospital de Base · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypotension

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Keywords

  • Ondansetron
  • Hypotension
  • Spinal anesthesia
03

In context

Hypotension

1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 686 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Hospital de Base is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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;
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Ondansetron group

    Patients will receive intravenous ondansetron before spinal anesthesia

    Drug: Prophylactic ondansetron

  • Placebo comparator
    Control group

    Patients will receive intravenous saline before spinal anesthesia

    Drug: Placebo

Interventions

  • DrugProphylactic ondansetron

    Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia

  • DrugPlacebo

    Pacients will receibe standard spinal anesthesia

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events as hypotension

    Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors

    Time frame: During surgery

07

Study locations

1 of 1 sites recruiting
  • Hospital de Base do Distrito Federal
    Brasília, Federal District 70680250, Brazil
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2019 (actual). Primary completion is estimated for Mar 2020, 12 months after the start.

Of 69 non-industry phase 4 interventional studies under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 12 months is close to that.

Counting every sponsor, half of 76 studies reached it within 12 months; a quarter within 5 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2019
First posted
Jun 4, 2019
StartActual
Mar 1, 2019
Primary completionEst.
Mar 2020
CompletionEst.
Mar 2020
Last update
Jun 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03973411
Lead sponsor
Hospital de Base
Responsible party
Fabricio Tavares Mendonca (Preceptor of medical residency in anesthesiology, Hospital de Base) — Principal investigator
First posted
Jun 4, 2019
Start date
Mar 1, 2019
Primary completion
Mar 2020 (estimated)
Completion
Mar 2020 (estimated)
Last update
Jun 4, 2019

Study contacts

Fabricio T Mendonça, MD
Contact
correiodofabricio@gmail.com
5561981882640
Fabricio T Mendonça, MD
principal investigator · Hospital de Base do Distrito Federal

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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