Comparing ondansetron lozenge versus IV ondansetron to prevent shivering during cesarean section
Official title: Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial
Run by Tanta University · NCT07511491 · Data updated 2026-11-12
This test will see if an ondansetron lozenge or IV ondansetron works better to prevent shivering in women having cesarean sections with spinal anesthesia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Status | Recruiting |
| Started | April 11, 2026 |
| Main results expected | August 30, 2026 |
| Study ends | August 30, 2026 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT07511491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–40 years with ASA physical status II who are scheduled for cesarean section under spinal anesthesia and have no contraindications to ondansetron are ideal candidates.
✕Probably not a fit
Patients with preoperative fever or shivering, cardiovascular disease, thyroid disorders, Parkinsonism, BMI over 40, substance abuse history, need for intraoperative transfusion, or known hypersensitivity to ondansetron are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study compares two routes of giving ondansetron—a dissolvable lozenge and an intravenous injection—in parturient women undergoing cesarean delivery with spinal anesthesia. Participants who meet inclusion criteria receive one of the two ondansetron interventions before or during the operation, and clinicians monitor for intraoperative and postoperative shivering and related outcomes. The protocol excludes patients with preoperative fever or shivering, significant comorbidities, or contraindications to ondansetron. Outcomes likely include incidence and severity of shivering and common side effects such as nausea and vomiting.
Why it matters
Potential benefit: If successful, this could reduce shivering and improve comfort and monitoring during and after cesarean delivery.
How similar studies have gone: Previous studies have shown IV ondansetron can reduce perioperative shivering and nausea, while use of an ondansetron lozenge for this purpose is less commonly reported but is pharmacologically plausible.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 40 years. * American Society of Anesthesiology (ASA) physical status II. * Parturient women undergoing cesarean section under spinal anesthesia. Exclusion Criteria: * Parturient women with any contraindication or hypersensitivity to the study drugs. * Any history of cardiovascular diseases, psychosis, hypertension, fetal distress, cord prolapse initial. * Preoperative shivering. * Preoperative fever (\>38°C). * Body mass index \> 40 kg/m2. * Medical history of alcohol or drug abuse. * Hypo- or hyperthyroidism. * Parkinson's disease or any extrapyramidal disease. * Intraoperative blood transfusion.
Where it's running
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Tanta University
Tanta, El-Gharbia, Egypt Recruiting
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.