Hernia, InguinalNCT06850740
Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy
A study testing Ondansetron 8mg and Normal Saline in people with Hernia, Inguinal, run by Suez Canal University at 1 site in Egypt.
Trial summary
Ondansetron, a selective serotonin 5-HT3 receptor antagonist, is well known for its antiemetic effects. However, its ability to reduce hypotension during spinal anesthesia has recently sparked great interest. In clinical practice, administering ondansetron before spinal anesthesia has produced promising results. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Ondansetron 8mg and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2025to 15 Aug 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for inguinal herniorrhaphy in Suez Canal University Hospitals
- Height: 150 to 180 cm.
- Body mass index (BMI): not more than 35 kg/m².
- Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients), ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).
Who cannot join
- Patients refused to participate in the study.
- Contraindications of spinal anesthesia.
- Known allergy to bupivacaine or ondansetron.
- Patients with a history of arrhythmia, especially those with prolonged QT intervals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy: A Randomized Controlled Trial
Ondansetron, a selective serotonin 5-HT3 receptor antagonist, is well known for its antiemetic effects. However, its ability to reduce hypotension during spinal anesthesia has recently sparked great interest. In clinical practice, administering ondansetron before spinal anesthesia has produced promising results.
Read the detailed description
This prospective randomized double-blinded controlled study will be conducted on 46 patients undergoing inguinal herniorrhaphy at Suez Canal University Hospital and will be randomly assigned to one of the two groups using a table of random numbers. Group A (23 patients) will be administered 8 mg of ondansetron diluted in 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis to be finished in 10 minutes. Group B (23 patients) will be administered 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis, to be finished in 10 minutes.
- Conditions
- Hernia, Inguinal
- Being tested
- Ondansetron 8mg, Normal Saline
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
Also called OND
Patients will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt)
Normal SalineDrug
Also called Saline
Patients will be managed by administering 100 ml of normal saline solution as placebo
| Study group | Role | What they receive |
|---|---|---|
| Ondansetrone | Active comparator | will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt) over 100 ml of normal saline solution over 10 minutes, starting with skin preparation for spinal anesthesia via the intravenous axis and a rapid intravenous (IV) infusion of 15 mL/kg of Ringer's solution that will be co-loaded during spinal anesthesia. Receives: Drug: Ondansetron 8mg |
| Saline | Placebo comparator | will be managed by administering 100 ml of normal saline solution over 10 minutes, starting with the skin preparation for spinal anesthesia via the intravenous axis and a rapid intravenous (IV) infusion of 15 mL/kg of Ringer's solution that will be co-loaded during spinal anesthesia. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ephedrine
Total intraoperative ephedrine consumption.
Measured: From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors
Secondary outcomes (1)
Nausea and vomiting
Incidence of post operative nausea and vomiting.
Measured: From the time of end of surgery till the pass of the first 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 posted27 Feb 2025
- Study start15 Mar 2025
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850740
- Sponsor's protocol ID
- Co ondansetrone
- Status last verified
- Apr 2025
- First submitted
- 22 Feb 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06850740
- Acronym / sponsor ID
- Co ondansetrone
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 27 Feb 2025 (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.
Ondansetron, a selective serotonin 5-HT3 receptor antagonist, is well known for its antiemetic effects. However, its ability to reduce hypotension during spinal anesthesia has recently sparked great interest. In clinical practice, administering ondansetron before spinal anesthesia has produced promising results.
Detailed description
This prospective randomized double-blinded controlled study will be conducted on 46 patients undergoing inguinal herniorrhaphy at Suez Canal University Hospital and will be randomly assigned to one of the two groups using a table of random numbers. Group A (23 patients) will be administered 8 mg of ondansetron diluted in 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis to be finished in 10 minutes. Group B (23 patients) will be administered 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis, to be finished in 10 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetrone | Active comparator | Drug: Ondansetron 8mgwill receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt) over 100 ml of normal saline solution over 10 minutes, starting with skin preparation for spinal anesthesia via the intravenous axis and a rapid intravenous (IV) infusion of 15 mL/kg of Ringer's solution that will be co-loaded during spinal anesthesia. |
| Saline | Placebo comparator | Drug: Normal Salinewill be managed by administering 100 ml of normal saline solution over 10 minutes, starting with the skin preparation for spinal anesthesia via the intravenous axis and a rapid intravenous (IV) infusion of 15 mL/kg of Ringer's solution that will be co-loaded during spinal anesthesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients scheduled for inguinal herniorrhaphy in Suez Canal University Hospitals
- Height: 150 to 180 cm.
- Body mass index (BMI): not more than 35 kg/m².
- Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients), ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).
Key exclusion criteria (4 listed)
- Patients refused to participate in the study.
- Contraindications of spinal anesthesia.
- Known allergy to bupivacaine or ondansetron.
- Patients with a history of arrhythmia, especially those with prolonged QT intervals.
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 8mgAlso: ONDPatients will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt) | Drug | Ondansetrone |
| Normal SalineAlso: SalinePatients will be managed by administering 100 ml of normal saline solution as placebo | Drug | Saline |
Primary outcome
Ephedrine
Time frame: From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors
Total intraoperative ephedrine consumption.
1 secondary outcome
Nausea and vomiting
Time frame: From the time of end of surgery till the pass of the first 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 30 Apr 2025.
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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.
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 8mg and Normal Saline in people with Hernia, Inguinal, run by Suez Canal 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
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?
Ephedrine (time frame: From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors). 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 30 Apr 2025.