Ondansetron LozengeNCT06423807
Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section
A study testing Ondansetron lozenge in people with Ondansetron Lozenge and Post-Spinal Shivering, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ondansetron Lozenge, Post-Spinal Shivering, Cesarean Section
- What is being tested?
- Ondansetron lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2024to 29 Sep 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 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 CS 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.
- Temperature more than 38°C or less than 36°C.
- Body Mass Index (BMI)> 40 kg/m2.
- Medical history of alcohol or drug abuse.
- Parkinson's disease or any extrapyramidal disease.
- Intraoperative blood transfusion.
- History of chemotherapy treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section: A Randomized Controlled Trial
The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.
Read the detailed description
Spinal anesthesia (SA) is preferred for cesarean section (CS) compared with general anesthesia(GA) because of several advantages, including prevention of the potential risk of GA-related neurotoxicity.
Post-spinal shivering (PSS) could be a provocative factor for postoperative pain and its appropriate treatment prevents non-thermoregulatory tremors. Shivering also causes aggravating postoperative pain by stretching of sutures.
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. Ondansetron can affect the body temperature and shivering in rats since the balance of nor-epinephrine and 5-hydroxytryptamine (5-HT) in the preoptic-anterior hypothalamus controls the temperature set point.
- Conditions
- Ondansetron Lozenge, Post-Spinal Shivering, Cesarean Section
- Being tested
- Ondansetron lozenge
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.
| Study group | Role | What they receive |
|---|---|---|
| Group S (Ondansetron lozenge) | Experimental | Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group. Receives: Drug: Ondansetron lozenge |
| Group C (Control) | 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, 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.
Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby.
Measured: 24 hours postoperatively
Secondary outcomes (3)
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
Patients' 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
Adverse events 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 posted21 May 2024
- Study start21 May 2024
- Primary completion29 Sep 2024
- Study completion29 Sep 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
- Investigators
- Mohammed S Elsharkawy, MD, Principal investigator, Faculty of Medicine Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423807
- Sponsor's protocol ID
- 36264PR642/4/24
- Status last verified
- Oct 2024
- First submitted
- 16 May 2024
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06423807
- Acronym / sponsor ID
- 36264PR642/4/24
- Conditions
- Ondansetron Lozenge, Post-Spinal Shivering, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 21 May 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 role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.
Detailed description
Spinal anesthesia (SA) is preferred for cesarean section (CS) compared with general anesthesia(GA) because of several advantages, including prevention of the potential risk of GA-related neurotoxicity.
Post-spinal shivering (PSS) could be a provocative factor for postoperative pain and its appropriate treatment prevents non-thermoregulatory tremors. Shivering also causes aggravating postoperative pain by stretching of sutures.
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. Ondansetron can affect the body temperature and shivering in rats since the balance of nor-epinephrine and 5-hydroxytryptamine (5-HT) in the preoptic-anterior hypothalamus controls the temperature set point.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S (Ondansetron lozenge) | Experimental | Drug: Ondansetron lozengePatients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group. |
| Group C (Control) | 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 CS under spinal anesthesia.
Key exclusion criteria (8 listed)
- Parturient women with any contraindication or hypersensitivity to the study drugs.
- Any history of cardiovascular diseases, psychosis, hypertension, fetal distress, cord prolapse initial.
- Temperature more than 38°C or less than 36°C.
- Body Mass Index (BMI)> 40 kg/m2.
- Medical history of alcohol or drug abuse.
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 S (Ondansetron lozenge) |
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. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby.
3 secondary outcomes
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 24 hours postoperatively
Patients' 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 8 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
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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.
Mohammed S Elsharkawy, MD principal investigator
Faculty of Medicine Tanta University, Egypt
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 in people with Ondansetron Lozenge and Post-Spinal Shivering, 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 8 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 8 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 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 8 Oct 2024.