Role of Ondansetron in Spinal Anaesthesia Induced Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ondansetron (Zofran), Saline (NaCl 0,9 %) (placebo).
- Who it may be relevant to
- Registry conditions: Spinal Anaesthesia Induced Hypotension. Basic parameters: 19 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Ondansetron on the Total Consumption of Norepinephrine Infusion Used to Prevent Spinal Anaesthesia Induced Hypotention in Cesarean Section.
Overview
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.
Interventions
- Drug Ondansetron (Zofran)
Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot. - Drug Saline (NaCl 0,9 %) (placebo)
normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia
Primary outcome measures
- Total consumption of norepinephrine during the whole surgical procedure. [Time frame: Just after subarachnoid block till the end of surgery]
Secondary outcome measures (1)
- Incidence of hypotension, hemodynamic data and postoperative complications(nausea,vomiting,hypertension and bradycardia). [Time frame: Just after subarachnoid block till 24 hours postoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Assiut university — Asyut
Publications
- Sheng ZM, Sun HQ, Mao JQ, Liu J, Liang G, Mei Z. Comparative dose-response study on the infusion of norepinephrine combined with intravenous ondansetron versus placebo for preventing hypotension during spinal anesthesia for cesarean section: a randomised controlled trial. Int J Surg. 2024 Feb 1;110(2):832-838. doi: 10.1097/JS9.0000000000000920. PMID 38000073
Identifiers
NCT: NCT06727201 · Role of ondansetron