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Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

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

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06727201
Enrollment
160
Registered
2024-12-10
Start date
2025-01-01
Completion date
2027-02-01
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anaesthesia Induced Hypotension

Keywords

Ondansetron, Spinal anaethesia, Hypotension, Norepinephrine

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.

Interventions

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

DRUGSaline (NaCl 0,9 %) (placebo)

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total consumption of norepinephrine during the whole surgical procedure.Just after subarachnoid block till the end of surgeryComparison between total amount of vassopressor used to maintain normal blood pressure in both groups of study

Secondary

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

Countries

Egypt

Contacts

Primary ContactWaleed T Farouk, Resident
Waleedtarek523@gmail.com+2001150903140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026