Cesarean DeliveryPhase 4NCT07322419
Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine
A Phase 4 study testing Spinal Anesthesia with Bupivacaine and Fentanyl, Crystalloid Coload 1000 mL and Cesarean Delivery in people with Cesarean Delivery and Spinal Anesthesia for Cesarean Section, run by Mansoura University at 1 site in Egypt.
Trial summary
Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Cesarean Delivery, Spinal Anesthesia for Cesarean Section
- What is being tested?
- Spinal Anesthesia with Bupivacaine and Fentanyl, Crystalloid Coload 1000 mL and Cesarean Delivery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status II.
- Singleton, full term pregnancy.
- Scheduled cesarean delivery under spinal anesthesia.
Who cannot join
- Height <150 or >180 cm.
- Weight <60 or >110 kg.
- Body mass index (BMI) <18.5 or ≥35 kg/m².
- Women presenting in labor.
- Any contraindication to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection.
- Chronic or pregnancy-induced hypertension.
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- Baseline systolic blood pressure >140 mm Hg.
- Hemoglobin <10 g/dl.
- Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease.
- Polyhydramnios or known significant fetal abnormalities.
- Current administration of vasoactive drugs such as: beta blockers, salbutamol, or thyroxin.
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, 1 recruiting
- Recruiting
Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
Mohamed M Tawfik, MD, 0020 1001183400, m2tawfik@mans.edu.eg
About this study
Official title: Echocardiographic Evaluation of Cardiac Output During Cesarean Delivery Under Spinal Anesthesia Using Norepinephrine Versus Ephedrine: A Randomized Controlled Trial
Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another group.
- Being tested
- Spinal Anesthesia with Bupivacaine and Fentanyl, Crystalloid Coload 1000 mL, Cesarean Delivery, Transthoracic Echocardiography, Intravenous Norepinephrine Bolus
- Keywords
- Cesarean delivery, Spinal anesthesia, Echocardiography, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia with Bupivacaine and FentanylProcedure or surgery
Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace
Crystalloid Coload 1000 mLDrug
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
Cesarean DeliveryProcedure or surgery
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
Transthoracic EchocardiographyRadiation
Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery
Intravenous Norepinephrine BolusDrug
Prophylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
Intravenous Ephedrine BolusDrug
Prophylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine | Experimental | Not described Receives: Procedure: Spinal Anesthesia with Bupivacaine and Fentanyl; Drug: Crystalloid Coload 1000 mL; Procedure: Cesarean Delivery; Radiation: Transthoracic Echocardiography; Drug: Intravenous Norepinephrine Bolus |
| Ephedrine | Active comparator | Not described Receives: Procedure: Spinal Anesthesia with Bupivacaine and Fentanyl; Drug: Crystalloid Coload 1000 mL; Procedure: Cesarean Delivery; Radiation: Transthoracic Echocardiography; Drug: Intravenous Ephedrine Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection
Measured: From the start of spinal anesthesia until delivery
Secondary outcomes (12)
Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery
Measured: From the start of spinal anesthesia until delivery
Differences between the 2 groups in stroke volume at 1 and 10 minutes after intrathecal injection, and after delivery
Measured: From the start of spinal anesthesia until delivery
Differences between the 2 groups in heart rate at 1 and 10 minutes after intrathecal injection, and after delivery
Measured: From the start of spinal anesthesia until delivery
Differences between the 2 groups in mean arterial pressure at 1 and 10 minutes after intrathecal injection, and after delivery
Measured: From the start of spinal anesthesia until delivery
Differences between the 2 groups in systemic vascular resistance at 1 and10 minutes after intrathecal injection, and after delivery
Measured: From the start of spinal anesthesia until delivery
Number of patients receiving rescue vasopressor
Systolic blood pressure <90% of baseline value
Measured: From the start of spinal anesthesia until delivery
Incidence of hypotension
Systolic blood pressure <80% of baseline value
Measured: From the start of spinal anesthesia until delivery
Incidence of severe hypotension
Systolic blood pressure <70% of baseline value
Measured: From the start of spinal anesthesia until delivery
Incidence of bradycardia
Heart rate <50 beats/min
Measured: From the start of spinal anesthesia until delivery
Incidence of nausea and/or vomiting
Measured: From the start of spinal anesthesia until delivery
Total vasopressor dose
Measured: From the start of spinal anesthesia until delivery
Neonatal Apgar score at 1 and 5 minutes after delivery
Scale from 0 to 10. Higher scores mean better outcomes.
Measured: 1 and 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Tawfik, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322419
- Sponsor's protocol ID
- MD.25.04.982
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be provided to the Publishing journal if requested
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Evaluation of Cardiac Output During Cesarean Delivery Under Spinal Anesthesia Using Norepinephrine Versus Ephedrine: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07322419
- Acronym / sponsor ID
- MD.25.04.982
- Keywords
- Cesarean delivery, Spinal anesthesia, Echocardiography, Hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jan 2026 (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.
Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine | Experimental | Procedure: Spinal Anesthesia with Bupivacaine and Fentanyl, Drug: Crystalloid Coload 1000 mL, Procedure: Cesarean Delivery, Radiation: Transthoracic Echocardiography, Drug: Intravenous Norepinephrine Bolus |
| Ephedrine | Active comparator | Procedure: Spinal Anesthesia with Bupivacaine and Fentanyl, Drug: Crystalloid Coload 1000 mL, Procedure: Cesarean Delivery, Radiation: Transthoracic Echocardiography, Drug: Intravenous Ephedrine Bolus |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status II.
- Singleton, full term pregnancy.
- Scheduled cesarean delivery under spinal anesthesia.
Key exclusion criteria (11 listed)
- Height <150 or >180 cm.
- Weight <60 or >110 kg.
- Body mass index (BMI) <18.5 or ≥35 kg/m².
- Women presenting in labor.
- Any contraindication to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection.
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 |
|---|---|---|
| Spinal Anesthesia with Bupivacaine and FentanylSpinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace | Procedure or surgery | Ephedrine, Norepinephrine |
| Crystalloid Coload 1000 mLRinger acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection | Drug | Ephedrine, Norepinephrine |
| Cesarean DeliveryLower segment cesarean section using the Pfannenstiel incision and uterine exteriorization | Procedure or surgery | Ephedrine, Norepinephrine |
| Transthoracic EchocardiographyMeasurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery | Radiation | Ephedrine, Norepinephrine |
| Intravenous Norepinephrine BolusProphylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively | Drug | Norepinephrine |
| Intravenous Ephedrine BolusProphylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively | Drug | Ephedrine |
Primary outcome
Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection
Time frame: From the start of spinal anesthesia until delivery
12 secondary outcomes
Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in stroke volume at 1 and 10 minutes after intrathecal injection, and after delivery
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in heart rate at 1 and 10 minutes after intrathecal injection, and after delivery
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in mean arterial pressure at 1 and 10 minutes after intrathecal injection, and after delivery
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in systemic vascular resistance at 1 and10 minutes after intrathecal injection, and after delivery
Time frame: From the start of spinal anesthesia until delivery
Number of patients receiving rescue vasopressor
Time frame: From the start of spinal anesthesia until delivery
Incidence of hypotension
Time frame: From the start of spinal anesthesia until delivery
Incidence of severe hypotension
Time frame: From the start of spinal anesthesia until delivery
Incidence of bradycardia
Time frame: From the start of spinal anesthesia until delivery
Incidence of nausea and/or vomiting
Time frame: From the start of spinal anesthesia until delivery
Total vasopressor dose
Time frame: From the start of spinal anesthesia until delivery
Neonatal Apgar score at 1 and 5 minutes after delivery
Time frame: 1 and 5 minutes after delivery
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 14 Jan 2026.
- Individual participant dataSharing planned: No. IPD will be provided to the Publishing journal if requested
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal Anesthesia with Bupivacaine and Fentanyl, Crystalloid Coload 1000 mL and Cesarean Delivery in people with Cesarean Delivery and Spinal Anesthesia for Cesarean Section, run by Mansoura 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 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: looking for participants now, as of the sponsor's last update on 14 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mohamed M Tawfik, MD (0020 1001183400, m2tawfik@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection (time frame: From the start of spinal anesthesia until delivery). 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 14 Jan 2026.