Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

December 6, 2024 updated by: Waleed Tarek Farouk, Assiut University

The Effect of Ondansetron on the Total Consumption of Norepinephrine Infusion Used to Prevent Spinal Anaesthesia Induced Hypotention in Cesarean Section.

The objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ondansetron has been reported to attenuate the incidence of spinal anaesthesia-induced hypotension (SAIH) and norepinephrine requirement during caesarean section.

The mechanism of hypotension following spinal anaesthesia involves the reduction in vascular resistance caused by the sympathetic block and the activation of the Bezold-Jarisch reflex, leading to vasodilation and hypotension. Peripheral serotonin receptors, 5-Hydroxytryptamine3 (5HT3), are required for the activation of the Bezold-Jarisch reflex. In a rabbit model, a 5-HT3 receptor antagonist was reported to suppress bradycardia and hypotension by preventing the Bezold-Jarisch reflex.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University
        • Contact:
          • Vice President of graduate studies of Assiut University
          • Phone Number: +208822080150
          • Email: vp_grad@aun.edu.eg

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age from 19 to 40 years old.
  • Singleton pregnancies with a gestational age of at least 37 weeks.
  • pregnant women are scheduled for elective caesarean delivery.
  • Patients with stable vital signs.
  • Patients with normal laboratory investigations.
  • patients undergoing spinal anaesthesia for caesarean delivery via Pfannenstiel incision with exteriorizaion of the uterus.

Exclusion Criteria:

  • Patient's refusal.
  • Age < 19 or > 40 years.
  • Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
  • Contraindications to spinal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
  • Patients with cardiac morbidities.
  • hypertensive disorders of pregnancy as pre-eclampsia.
  • peripartum bleeding.
  • Patients with respiratory morbidities.
  • Convulsions.
  • Bleeding diathesis.
  • Known allergy to any drugs used in this study.

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ondansetron (Zofran)
Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot
Drug: Ondansetron (Zofran)
Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot.
Placebo Comparator: Saline placebo
Normal saline will be administered by intravenous infusion 10 minutes before spinal anaesthesia
Drug: Saline (NaCl 0,9 %) (placebo)
normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total consumption of norepinephrine during the whole surgical procedure.
Time Frame: Just after subarachnoid block till the end of surgery
Comparison between total amount of vassopressor used to maintain normal blood pressure in both groups of study
Just after subarachnoid block till the end of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of hypotension, hemodynamic data and postoperative complications(nausea,vomiting,hypertension and bradycardia).
Time Frame: Just after subarachnoid block till 24 hours postoperative
Just after subarachnoid block till 24 hours postoperative

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Mohamed H Bakri, professor, Assiut University
  • Study Director: Ola M Wahba, A.professor, Assiut University
  • Study Director: Abdelrahman H Mohammed, A.professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Role of ondansetron

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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