Hypotension After Spinal AnesthesiaNCT07037654
Lingual Ondansetron in Reduction of Spinal Hypotension in Cesarean Section
A study testing ondansetron lingual film in people with Hypotension After Spinal Anesthesia, run by Suez Canal University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if drug ondansetron, used in lingual form, lowers the incidence of spinal anesthesia-induced hypotension in cesarean sections. It will also learn about the safety of drug ondansetron. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypotension After Spinal Anesthesia
- What is being tested?
- ondansetron lingual film
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Sep 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: 18- 40 years old parturients.
- Height: 150 to 180 cm
- Patients are ASA II (American Society of Anesthesiologists physical status grade II) = (pregnant and patients with mild systemic disease and no functional limitations).
- Patients scheduled for elective cesarean section in Suez Canal University Hospitals.
Who cannot join
- Patients' refused to participate in the study.
- Contraindications of spinal anesthesia (patients with marked deformities or infections at the site of spinal injection, and coagulopathy).
- Known allergy to bupivacaine or ondansetron.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lingual Ondansetron in Reduction of Spinal Anesthesia-induced Hypotension In Cesarean Section; a Randomized Controlled Trial
The goal of this clinical trial is to learn if drug ondansetron, used in lingual form, lowers the incidence of spinal anesthesia-induced hypotension in cesarean sections. It will also learn about the safety of drug ondansetron. The main questions it aims to answer are
Does the drug ondansetron, used in lingual form, lower the incidence of spinal anesthesia-induced hypotension in cesarean sections? What medical problems do participants have when taking the drug ondansetron? Researchers will compare drug ondansetron to a placebo (a look-alike substance that contains no drug) to see if drug ondansetron works to reduce the incidence of spinal anesthesia-induced hypotension in cesarean sections
Read more
Participants will:
Take drug ondansetron or a placebo before induction of spinal anesthesia
Read the detailed description
Spinal anesthesia, which is extensively used in a variety of surgical operations, frequently causes hypotension due to sympathetic nerve blocking. This reduction in blood pressure might have negative consequences, especially in people with cardiovascular comorbidities. 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 sparked great interest in recent years. Thus, it regulates cardiovascular function, vasodilation, and vascular tone and helps to maintain a more steady hemodynamic profile during spinal anesthesia.
A growing amount of evidence supports the use of ondansetron as a preventive strategy against spinal anesthesia-induced hypotension. This technique not only improves patient safety but also minimizes intraoperative problems. As research advances, using ondansetron in anesthetic protocols may become commonplace, reflecting its numerous benefits in the perioperative situation.
Objective: To investigate the efficacy of the lingual film form of ondansetron after use in parturients undergoing spinal anesthesia during cesarean delivery to reduce total ephedrine consumption and spinal-induced hypotension.
Methodology: Following the administrative ethical committee approval and informed patient consent obtained from 112 patients undergoing cesarean delivery in Suez Canal University Hospital, they will be randomly assigned to one of the two groups using a computer software program.
Group A (56 patients) will be administered 8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia.
Group B (56 patients) will be administered a placebo lingual film form 15 minutes before spinal anesthesia.
Expected outcome: The investigators can expect a reduction in the total ephedrine consumption and more cardiovascular stability based on the previous trial.
- Conditions
- Hypotension After Spinal Anesthesia
- Being tested
- ondansetron lingual film, Placebo
- Keywords
- spinal anesthesia, lingual ondansetron, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetron lingual filmDrug
8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia
PlaceboDrug
a placebo lingual film form, given 15 minutes before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| ondansetron | Active comparator | 8 mg of the lingual film form of ondansetron will be given 15 minutes before spinal anesthesia Receives: Drug: ondansetron lingual film |
| placebo | Placebo comparator | a placebo lingual film form will be given 15 minutes before spinal anesthesia Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ephidrine consumption
To evaluate the impact of lingual ondansetron on parturients having cesarean sections' overall intraoperative ephedrine consumption
Measured: From the moment the surgery starts until it is finished, or after 90 minutes has passed, whichever is longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension After Spinal AnesthesiaStudies 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
- 112 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
- Investigators
- Abdelrhman Alshawadfy, Principal investigator, Faculty of Medicine, Suez Canal University Ismailia, , Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037654
- Sponsor's protocol ID
- Lingual ondansetron
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lingual Ondansetron in Reduction of Spinal Anesthesia-induced Hypotension In Cesarean Section; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07037654
- Acronym / sponsor ID
- Lingual ondansetron
- Conditions
- Hypotension After Spinal Anesthesia
- Keywords
- spinal anesthesia, lingual ondansetron, cesarean section
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Jun 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.
The goal of this clinical trial is to learn if drug ondansetron, used in lingual form, lowers the incidence of spinal anesthesia-induced hypotension in cesarean sections. It will also learn about the safety of drug ondansetron. The main questions it aims to answer are
Does the drug ondansetron, used in lingual form, lower the incidence of spinal anesthesia-induced hypotension in cesarean sections? What medical problems do participants have when taking the drug ondansetron? Researchers will compare drug ondansetron to a placebo (a look-alike substance that contains no drug) to see if drug ondansetron works to reduce the incidence of spinal anesthesia-induced hypotension in cesarean sections
Participants will:
Take drug ondansetron or a placebo before induction of spinal anesthesia
Detailed description
Spinal anesthesia, which is extensively used in a variety of surgical operations, frequently causes hypotension due to sympathetic nerve blocking. This reduction in blood pressure might have negative consequences, especially in people with cardiovascular comorbidities. 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 sparked great interest in recent years. Thus, it regulates cardiovascular function, vasodilation, and vascular tone and helps to maintain a more steady hemodynamic profile during spinal anesthesia.
A growing amount of evidence supports the use of ondansetron as a preventive strategy against spinal anesthesia-induced hypotension. This technique not only improves patient safety but also minimizes intraoperative problems. As research advances, using ondansetron in anesthetic protocols may become commonplace, reflecting its numerous benefits in the perioperative situation.
Objective: To investigate the efficacy of the lingual film form of ondansetron after use in parturients undergoing spinal anesthesia during cesarean delivery to reduce total ephedrine consumption and spinal-induced hypotension.
Methodology: Following the administrative ethical committee approval and informed patient consent obtained from 112 patients undergoing cesarean delivery in Suez Canal University Hospital, they will be randomly assigned to one of the two groups using a computer software program.
Group A (56 patients) will be administered 8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia.
Group B (56 patients) will be administered a placebo lingual film form 15 minutes before spinal anesthesia.
Expected outcome: The investigators can expect a reduction in the total ephedrine consumption and more cardiovascular stability based on the previous trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ondansetron | Active comparator | Drug: ondansetron lingual film8 mg of the lingual film form of ondansetron will be given 15 minutes before spinal anesthesia |
| placebo | Placebo comparator | Drug: Placeboa placebo lingual film form will be given 15 minutes before spinal anesthesia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18- 40 years old parturients.
- Height: 150 to 180 cm
- Patients are ASA II (American Society of Anesthesiologists physical status grade II) = (pregnant and patients with mild systemic disease and no functional limitations).
- Patients scheduled for elective cesarean section in Suez Canal University Hospitals.
Key exclusion criteria (3 listed)
- Patients' refused to participate in the study.
- Contraindications of spinal anesthesia (patients with marked deformities or infections at the site of spinal injection, and coagulopathy).
- Known allergy to bupivacaine or ondansetron.
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 lingual film8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia | Drug | ondansetron |
| Placeboa placebo lingual film form, given 15 minutes before spinal anesthesia | Drug | placebo |
Primary outcome
ephidrine consumption
Time frame: From the moment the surgery starts until it is finished, or after 90 minutes has passed, whichever is longer
To evaluate the impact of lingual ondansetron on parturients having cesarean sections' overall intraoperative ephedrine consumption
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 27 May 2026.
Related trials for Hypotension After Spinal Anesthesia
RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
Incidence of Post-spinal Hypotension
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
RecruitingObservational study
Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
Hypotension, Spinal Anesthesia
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.
Abdelrhman Alshawadfy principal investigator
Faculty of Medicine, Suez Canal University Ismailia, , 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 lingual film in people with Hypotension After Spinal Anesthesia, 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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 May 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. 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?
ephidrine consumption (time frame: From the moment the surgery starts until it is finished, or after 90 minutes has passed, whichever is longer). 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 27 May 2026.