Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

Last updated: December 6, 2024
Sponsor: Assiut University
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Circulation Disorders

Dizzy/fainting Spells

Vascular Diseases

Treatment

Ondansetron (Zofran)

Saline (NaCl 0,9 %) (placebo)

Clinical Study ID

NCT06727201
Role of ondansetron
  • Ages 19-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 Pfannenstielincision with exteriorizaion of the uterus.

Exclusion

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 intracranialpressure, 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 Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Ondansetron (Zofran)
Phase: 2/3
Study Start date:
January 01, 2025
Estimated Completion Date:
February 01, 2027

Study 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.

Connect with a study center

  • Assiut university

    Assiut,
    Egypt

    Site Not Available

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