Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

Phase 2

Not yet recruiting

• Conditions: Spinal Anaesthesia Induced Hypotension
• Interventions: Drug: Ondansetron (Zofran); Drug: Saline (NaCl 0,9 %) (placebo)

• Registration Number: NCT06727201
• Lead Sponsor: Assiut University

Brief 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.

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 Timeline

• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2025-01-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ondansetron (Zofran)	Ondansetron (Zofran)	Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot
Saline placebo	Saline (NaCl 0,9 %) (placebo)	Normal saline will be administered by intravenous infusion 10 minutes before spinal anaesthesia

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt