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NCT Number: NCT06727201

Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

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.

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Key information

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ondansetron (Zofran)

Drug

Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot.

Saline (NaCl 0,9 %) (placebo)

Drug

normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of hypotension, hemodynamic data and postoperative complications(nausea,vomiting,hypertension and bradycardia).

    Time frame: Just after subarachnoid block till 24 hours postoperative

Study contacts

Contact information is provided by the study sponsor or research team.

Waleed T Farouk, Resident

CONTACT

[email protected]

+2001150903140

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

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.

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