Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section

August 23, 2019 updated by: Mostafa Samy Abbas, Assiut University

Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study

Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is associated with hypotension and bradycardia, which may be deleterious to both parturient and baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following subarachnoid block in parturients undergoing elective caesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Asyut Governorate
      • Assiut, Asyut Governorate, Egypt, 11111
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Undergoing an elective lower segment caesarean section.

Exclusion Criteria:

  • Patients with contraindications to subarachnoid block (patient refusal, unstable haemodynamics, coagulation abnormality),
  • History of hypersensitivity to ondansetron or local anaesthetic agents,
  • Hypertensive disorders of pregnancy,
  • Cardiovascular insufficiency,
  • Receiving selective serotonin reuptake inhibitors or migraine medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ondansetron
Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia
Drug: Ondansetron
Placebo Comparator: control
Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia
Drug: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotension
Time Frame: intraoperative
Systolic BP <90 mmHg or Diastolic BP <60 mmHg
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bradycardia
Time Frame: intraoperative
HR <50 beats/min
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ondansetron for CS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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