Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia

NCT03973411 | Unknown Phase 4

• 1 other identifier: Ondansetron for spinal
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypotension

Keywords

Ondansetron; Hypotension; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as hypotension

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

  During surgery

Study Arms (2)

Ondansetron group

ACTIVE COMPARATOR

Patients will receive intravenous ondansetron before spinal anesthesia

Drug: Prophylactic ondansetron

Control group

PLACEBO COMPARATOR

Patients will receive intravenous saline before spinal anesthesia

Drug: Placebo

Interventions

Prophylactic ondansetron DRUG

Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia

Ondansetron group

Placebo DRUG

Pacients will receibe standard spinal anesthesia

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70680250, Brazil

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Fabricio T Mendonça, MD

  Hospital de Base do Distrito Federal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabricio T Mendonça, MD

CONTACT

5561981882640; correiodofabricio@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Preceptor of medical residency in anesthesiology

Model Details: Prospective, randomized, duble-blind and placebo-controlled trial

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 4, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

BR (1)