Spinal Anaesthesia Induced HypotensionPhase 2/3NCT06727201
Role of Ondansetron in Spinal Anaesthesia Induced Hypotension
A Phase 2/3 study testing Ondansetron (Zofran) in people with Spinal Anaesthesia Induced Hypotension, run by Assiut University at 1 site in Egypt.
Trial summary
The objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anaesthesia Induced Hypotension
- What is being tested?
- Ondansetron (Zofran)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Feb 2027
- Phase
- Phase 2/3
- 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 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 19 to 40 years old.
- Singleton pregnancies with a gestational age of at least 37 weeks.
- pregnant women are scheduled for elective caesarean delivery.
- Patients with stable vital signs.
- Patients with normal laboratory investigations.
- patients undergoing spinal anaesthesia for caesarean delivery via Pfannenstiel incision with exteriorizaion of the uterus.
Who cannot join
- Patient's refusal.
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Contraindications to spinal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Patients with cardiac morbidities.
- hypertensive disorders of pregnancy as pre-eclampsia.
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- peripartum bleeding.
- Patients with respiratory morbidities.
- Convulsions.
- Bleeding diathesis.
- Known allergy to any drugs used in this study.
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
Assiut university
Asyut
Vice president of graduate studies of assiut university, +208822080150, vp_grad@aun.edu.eg
About this study
Official title: The Effect of Ondansetron on the Total Consumption of Norepinephrine Infusion Used to Prevent Spinal Anaesthesia Induced Hypotention in Cesarean Section.
The objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.
Read the detailed description
Ondansetron has been reported to attenuate the incidence of spinal anaesthesia-induced hypotension (SAIH) and norepinephrine requirement during caesarean section.
The mechanism of hypotension following spinal anaesthesia involves the reduction in vascular resistance caused by the sympathetic block and the activation of the Bezold-Jarisch reflex, leading to vasodilation and hypotension. Peripheral serotonin receptors, 5-Hydroxytryptamine3 (5HT3), are required for the activation of the Bezold-Jarisch reflex. In a rabbit model, a 5-HT3 receptor antagonist was reported to suppress bradycardia and hypotension by preventing the Bezold-Jarisch reflex.
- Conditions
- Spinal Anaesthesia Induced Hypotension
- Being tested
- Ondansetron (Zofran), Saline (NaCl 0,9 %) (placebo)
- Keywords
- Ondansetron, Spinal anaethesia, Hypotension, Norepinephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron (Zofran)Drug
Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot.
Saline (NaCl 0,9 %) (placebo)Drug
normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron (Zofran) | Active comparator | Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot Receives: Drug: Ondansetron (Zofran) |
| Saline placebo | Placebo comparator | Normal saline will be administered by intravenous infusion 10 minutes before spinal anaesthesia Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total consumption of norepinephrine during the whole surgical procedure.
Comparison between total amount of vassopressor used to maintain normal blood pressure in both groups of study
Measured: Just after subarachnoid block till the end of surgery
Secondary outcomes (1)
Incidence of hypotension, hemodynamic data and postoperative complications(nausea,vomiting,hypertension and bradycardia).
Measured: Just after subarachnoid block till 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Anaesthesia Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Tarek Farouk, Assiut University
- Investigators
- Mohamed H Bakri, professor, Study director, Assiut UniversityOla M Wahba, A.professor, Study director, Assiut UniversityAbdelrahman H Mohammed, A.professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727201
- Sponsor's protocol ID
- Role of ondansetron
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sheng ZM, Sun HQ, Mao JQ, Liu J, Liang G, Mei Z. Comparative dose-response study on the infusion of norepinephrine combined with intravenous ondansetron versus placebo for preventing hypotension during spinal anesthesia for cesarean section: a randomised controlled trial. Int J Surg. 2024 Feb 1;110(2):832-838. doi: 10.1097/JS9.0000000000000920.
PubMed 38000073
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ondansetron on the Total Consumption of Norepinephrine Infusion Used to Prevent Spinal Anaesthesia Induced Hypotention in Cesarean Section.
- ClinicalTrials.gov ID
- NCT06727201
- Acronym / sponsor ID
- Role of ondansetron
- Conditions
- Spinal Anaesthesia Induced Hypotension
- Keywords
- Ondansetron, Spinal anaethesia, Hypotension, Norepinephrine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 10 Dec 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 objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.
Detailed description
Ondansetron has been reported to attenuate the incidence of spinal anaesthesia-induced hypotension (SAIH) and norepinephrine requirement during caesarean section.
The mechanism of hypotension following spinal anaesthesia involves the reduction in vascular resistance caused by the sympathetic block and the activation of the Bezold-Jarisch reflex, leading to vasodilation and hypotension. Peripheral serotonin receptors, 5-Hydroxytryptamine3 (5HT3), are required for the activation of the Bezold-Jarisch reflex. In a rabbit model, a 5-HT3 receptor antagonist was reported to suppress bradycardia and hypotension by preventing the Bezold-Jarisch reflex.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron (Zofran) | Active comparator | Drug: Ondansetron (Zofran)Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot |
| Saline placebo | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)Normal saline will be administered by intravenous infusion 10 minutes before spinal anaesthesia |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age from 19 to 40 years old.
- Singleton pregnancies with a gestational age of at least 37 weeks.
- pregnant women are scheduled for elective caesarean delivery.
- Patients with stable vital signs.
- Patients with normal laboratory investigations.
Key exclusion criteria (11 listed)
- Patient's refusal.
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Contraindications to spinal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Patients with cardiac morbidities.
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 (Zofran)Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot. | Drug | Ondansetron (Zofran) |
| Saline (NaCl 0,9 %) (placebo)normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia | Drug | Saline placebo |
Primary outcome
Total consumption of norepinephrine during the whole surgical procedure.
Time frame: Just after subarachnoid block till the end of surgery
Comparison between total amount of vassopressor used to maintain normal blood pressure in both groups of study
1 secondary outcome
Incidence of hypotension, hemodynamic data and postoperative complications(nausea,vomiting,hypertension and bradycardia).
Time frame: Just after subarachnoid block till 24 hours postoperative
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 10 Dec 2024.
- Results publication: PubMed 38000073Sheng ZM, Sun HQ, Mao JQ, Liu J, Liang G, Mei Z. Comparative dose-response study on the infusion of norepinephrine combined with intravenous ondansetron versus placebo for preventing hypotension during spinal anesthesia for cesarean section: a randomised controlled trial. Int J Surg. 2024 Feb 1;110(2):832-838. doi: 10.1097/JS9.0000000000000920.
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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.
Mohamed H Bakri, professor study director
Assiut University
Ola M Wahba, A.professor study director
Assiut University
Abdelrahman H Mohammed, A.professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ondansetron (Zofran) in people with Spinal Anaesthesia Induced Hypotension, run by Assiut 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Dec 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. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Waleed T Farouk, Resident (+2001150903140, Waleedtarek523@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total consumption of norepinephrine during the whole surgical procedure. (time frame: Just after subarachnoid block till the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06727201, which also lists 1 linked publication.
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 10 Dec 2024.