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Interest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section

NCT02862873 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-08-11

No results posted yet for this study

Summary

The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP).

The expected results are a decrease in the frequency and severity of hypotension, thus leading to improved comfort for the mother and decreased maternal and foetal morbidity. Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation, with sometimes severe consequences for neonates.

It has been established that episodes of hypotension alter foetal pH. Investigators therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the infant.

One of the objectives of this study is also to observe a decrease in the quantity of vasopressors used and thus to avoid the adverse effects of their use in high doses.

The expected results are thus an improvement in haemodynamic stability during spinal anaesthesia for caesarean section.

The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive Arterial Pressure) as the collection of haemodynamic data will allow greater precision with the continuous measurement of AP, as well as a study of maternal cardiac output.

Conditions

Interventions

PROCEDURE

Spinal anaesthesia

DRUG

Ondansetron

OTHER

saline solution

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-05-31

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT02862873 on ClinicalTrials.gov