OndansetronNCT07511491
Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section
A study testing Ondansetron lozenge and Ondansetron intravenous in people with Ondansetron and Lozenge, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ondansetron, Lozenge, Intravenous
- What is being tested?
- Ondansetron lozenge and Ondansetron intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 40 years.
- American Society of Anesthesiology (ASA) physical status II.
- Parturient women undergoing cesarean section under spinal anesthesia.
Who cannot join
- 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.
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- Hypo- or hyperthyroidism.
- Parkinson's disease or any extrapyramidal disease.
- Intraoperative blood transfusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
Salma E Kandil, MD
About this study
Official title: Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).
Read the detailed description
Spinal anesthesia has many advantages when used for cesarean section (CS). It is a popular technique with rapid onset and high success rate.
Shivering is associated with increased metabolic activity and consumption of oxygen. In addition, arterial hypoxia, lactic acidosis, and interference with electrocardiogram monitoring could be associated with shivering.
Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation. This medicine also decreases nausea and vomiting intra-and post-operatively.
- Conditions
- Ondansetron, Lozenge, Intravenous, Prevention, Shivering, Cesarean Section
- Being tested
- Ondansetron lozenge, Ondansetron intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron lozengeDrug
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Ondansetron intravenousDrug
Patients will receive 8 mg of ondansetron IV just before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. Receives: Drug: Ondansetron lozenge |
| Group O | Experimental | Patients will receive 8 mg of ondansetron IV just before the surgery. Receives: Drug: Ondansetron intravenous |
| Group C | No intervention | Patients will not receive ondansetron as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of shivering
Shivering will be graded during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan and Tsai and Chu.
0 No shivering
- Piloerection or peripheral vasoconstriction but no visible shivering
- Muscular activity in only one muscle group
- Muscular activity in more than one muscle group but not generalized shivering
- Shivering involving the whole body
Measured: 24 hours postoperatively
Secondary outcomes (3)
Incidence of postoperative nausea and vomiting
The incidence of nausea and vomiting will be evaluated through the Bellville scoring scale (lack of nausea and vomiting=0, nausea=1, nausea with belching=2, and vomiting=3).
Measured: 24 hours postoperatively
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hours postoperatively
Incidence of adverse effects
Incidence of adverse effects such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start11 Apr 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OndansetronStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511491
- Sponsor's protocol ID
- 36264PR1310184/2/26
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07511491
- Acronym / sponsor ID
- 36264PR1310184/2/26
- Conditions
- Ondansetron, Lozenge, Intravenous, Prevention, Shivering, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).
Detailed description
Spinal anesthesia has many advantages when used for cesarean section (CS). It is a popular technique with rapid onset and high success rate.
Shivering is associated with increased metabolic activity and consumption of oxygen. In addition, arterial hypoxia, lactic acidosis, and interference with electrocardiogram monitoring could be associated with shivering.
Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation. This medicine also decreases nausea and vomiting intra-and post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Drug: Ondansetron lozengePatients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
| Group O | Experimental | Drug: Ondansetron intravenousPatients will receive 8 mg of ondansetron IV just before the surgery. |
| Group C | No intervention | –Patients will not receive ondansetron as a control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 18 to 40 years.
- American Society of Anesthesiology (ASA) physical status II.
- Parturient women undergoing cesarean section under spinal anesthesia.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron lozengePatients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. | Drug | Group L |
| Ondansetron intravenousPatients will receive 8 mg of ondansetron IV just before the surgery. | Drug | Group O |
Primary outcome
Incidence of shivering
Time frame: 24 hours postoperatively
Shivering will be graded during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan and Tsai and Chu. 0 No shivering 1. Piloerection or peripheral vasoconstriction but no visible shivering 2. Muscular activity in only one muscle group 3. Muscular activity in more than one muscle group but not generalized shivering 4. Shivering involving the whole body
3 secondary outcomes
Incidence of postoperative nausea and vomiting
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Incidence of adverse effects
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron lozenge and Ondansetron intravenous in people with Ondansetron and Lozenge, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed S Elsharkawy, MD (00201148207870, mselsharkawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of shivering (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.