Ondansetron LozengeNCT06254131
Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section
A study testing Ondansetron lozenge (Ondalenz ©) and Ondansetron IV in people with Ondansetron Lozenge and Postoperative Nausea and Vomiting, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Ondansetron Lozenge, Postoperative Nausea and Vomiting, Caesarean Section
- What is being tested?
- Ondansetron lozenge (Ondalenz ©) and Ondansetron IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 5 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 35 years old.
- American Society of Anesthesiologists (ASA) physical status II.
- Undergoing caesarean section under general anesthesia.
Who cannot join
- Medical history of alcohol or drug abuse.
- History of allergic reactions or intolerance to any study medications.
- BMI > 40 kg/m2.
- History of nausea and/or vomiting within 24 h prior procedures.
- History of treatment with antiemetic medication for nausea or vomiting within 24 h of their procedure.
- History of chemotherapy treatment within 4 weeks prior to surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section: A Randomized Controlled Trial
The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.
Read the detailed description
Caesarean section has become increasingly popular, and it is the most performed surgical procedure. Despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. Around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (PONV).
PONV may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost.
The latest guidelines for the management of PONV recommend the administration of prophylactic antiemetic drugs (AED) as part of a multimodal therapy in high-risk adults.
Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects
- Being tested
- Ondansetron lozenge (Ondalenz ©), Ondansetron IV
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron lozenge (Ondalenz ©)Drug
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
Ondansetron IVDrug
Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron lozenge (Ondalenz ©) | Experimental | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. Receives: Drug: Ondansetron lozenge (Ondalenz ©) |
| Ondansetron IV | Experimental | Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery. Receives: Drug: Ondansetron IV |
| Control group | 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 postoperative nausea and vomiting (PONV)
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
Secondary outcomes (3)
Severity of postoperative nausea and vomiting (PONV)
Severity of postoperative nausea and vomiting will be scored at 0-4, 4-12, 12-24 hours using Nausea vomiting scores (NVS): [(0, No complaint; 1, Mild degree of nausea; 2, Moderate degree of nausea; 3, Frequent vomiting; 4, Severe vomiting (continuously)].
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
Adverse effects
Side effects including headache, dry mouth, dizziness, visual disturbances, agitation, and sedation, will be evaluated on admission to the post anesthesia care unit (PACU) until discharge from the hospital.
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 posted12 Feb 2024
- Study start10 Feb 2024
- Primary completion5 Oct 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ondansetron LozengeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ِAhmed Mohamed Ibrahim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254131
- Sponsor's protocol ID
- 36264PR460/12/2023
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06254131
- Acronym / sponsor ID
- 36264PR460/12/2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 12 Feb 2024 (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.
The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.
Detailed description
Caesarean section has become increasingly popular, and it is the most performed surgical procedure. Despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. Around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (PONV).
PONV may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost.
The latest guidelines for the management of PONV recommend the administration of prophylactic antiemetic drugs (AED) as part of a multimodal therapy in high-risk adults.
Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ondansetron lozenge (Ondalenz ©) | Experimental | Drug: Ondansetron lozenge (Ondalenz ©)Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. |
| Ondansetron IV | Experimental | Drug: Ondansetron IVPatients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery. |
| Control group | No intervention | –Patients will not receive ondansetron as a control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 18 to 35 years old.
- American Society of Anesthesiologists (ASA) physical status II.
- Undergoing caesarean section under general anesthesia.
Key exclusion criteria (6 listed)
- Medical history of alcohol or drug abuse.
- History of allergic reactions or intolerance to any study medications.
- BMI > 40 kg/m2.
- History of nausea and/or vomiting within 24 h prior procedures.
- History of treatment with antiemetic medication for nausea or vomiting within 24 h of their procedure.
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 lozenge (Ondalenz ©)Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery. | Drug | Ondansetron lozenge (Ondalenz ©) |
| Ondansetron IVPatients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery. | Drug | Ondansetron IV |
Primary outcome
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 24 hours postoperatively
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).
3 secondary outcomes
Severity of postoperative nausea and vomiting (PONV)
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Adverse effects
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- 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.
Related trials for Ondansetron Lozenge
Recruiting
Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section
Ondansetron, Lozenge
Recruiting
Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy
Ondansetron, Lozenge
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (Ondalenz ©) and Ondansetron IV in people with Ondansetron Lozenge and Postoperative Nausea and Vomiting, 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 6 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: finished, as of the sponsor's last update on 22 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (PONV) (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 22 Oct 2024.