Skip to main content
OpenTrials
Completed

NCT Number: NCT02913768

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron

Drug

normal saline

Drug

Primary outcomes

  1. Hypotension

    Time frame: intraoperative

    Systolic BP <90 mmHg or Diastolic BP <60 mmHg

Secondary outcomes

  1. Bradycardia

    Time frame: intraoperative

    HR <50 beats/min

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 26, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.