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Effects of Ondansetron on Hemodynamics in Cesarean Section Under Spinal Anesthesia

NCT03629522 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-08-14

No results posted yet for this study

Summary

BACKGROUND:

Spinal anesthesia (SA) induced maternal hypotension is the most frequent and troublesome complication in cesarean section (CS), compromising both maternal and neonatal well-being. Many strategies have been used to prevent its occurrence but no single technique has been confirmed to be completely effective. the investigators hypothesized that ondansetron, a serotonin-receptor-antagonist, could have beneficial effects on maternal hemodynamics during CS under SA.

METHODS:

In this prospective double-blind placebo-controlled study, one hundred healthy parturients were randomized to receive either 8 mg of intravenous ondansetron (group O) or the same volume of saline (group S), 5 minutes prior to the induction of SA. All women received a coloading volume of 500 ml of saline. Maternal hemodynamics: blood pressure, heart rate and cardiac output (CO) were measured with a non-invasive device based on pulse wave transit time: the esCCO device Nihon Kohden hemodynamic monitor. Ephedrine was administered to treat hypotension (systolic blood pressure less than 80% of baseline).

Conditions

  • Ondansetron
  • Cesarean Section
  • Spinal Anesthesia
  • Hemodynamics

Interventions

DRUG

Ondansetron 8Mg/4mL Injection

investigators administrated intravenously Ondansetron 8 mg 5 minutes before spinal anesthesia.

Sponsors & Collaborators

  • University Hospital, Mahdia

    lead OTHER

Principal Investigators

  • bechir haddad, professor · tunisian Ministry of Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2017-11-30
Completion
2017-12-30

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629522 on ClinicalTrials.gov