Role of Ondansetron in Spinal Anaesthesia Induced Hypotension (NCT06727201) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Role of Ondansetron in Spinal Anaesthesia Induced Hypotension
Egypt160 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
19 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total consumption of norepinephrine during the whole surgical procedure.
Timeframe: Just after subarachnoid block till the end of surgery