Clinical trial Recruiting at 1 site Interventional Ages 18 to 40 Women only

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 typeInterventional
Ages18 Years to 40 Years
SexWomen only
Enrollment90 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta, El-Gharbia)
StatusRecruiting
StartedApril 11, 2026
Main results expectedAugust 30, 2026
Study endsAugust 30, 2026
Registry record updatedJune 23, 2026
Trial IDNCT07511491 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

  • Tanta University
    Tanta, El-Gharbia, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.