Ireland
--:--IST
Starting soon Phase 2/3

Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

NCT06727201 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 2/3
Started
2025-01-01
Last updated
2024-12-10

Condition(s) studied

Spinal Anaesthesia Induced Hypotension

Investigational drug(s) / intervention(s)

Ondansetron (Zofran) →Saline (NaCl 0,9 %) (placebo)

Ondansetron (Zofran): 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): normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia

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

Sex
FEMALE
Min age
19 Years
Max age
40 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Total consumption of norepinephrine during the whole surgical procedure. — 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

Trial sites (1)

FacilityCityRegionStatus
Assiut university Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06727201 on ClinicalTrials.gov ↗ ← All trials in Egypt