Comparing ondansetron lozenge versus IV ondansetron to prevent shivering during cesarean section
Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07511491 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.