Norepinephrine versus ephedrine for blood pressure control during cesarean with spinal anesthesia.
Echocardiographic Evaluation of Cardiac Output During Cesarean Delivery Under Spinal Anesthesia Using Norepinephrine Versus Ephedrine: A Randomized Controlled Trial
This test will see if norepinephrine or ephedrine better keeps blood pressure and cardiac output stable during spinal anesthesia for healthy women having a scheduled full‑term cesarean.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 19 Years to 40 Years |
| Sex | Female |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT07322419 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional trial enrolls healthy, ASA II women with full‑term singleton pregnancies scheduled for cesarean delivery under spinal anesthesia. Participants receive standard spinal anesthesia with bupivacaine and fentanyl plus a 1000 mL crystalloid coload and are randomized to receive either intravenous norepinephrine or ephedrine bolus as the vasopressor. Transthoracic echocardiography is used perioperatively to measure cardiac output and derive other hemodynamic variables while blood pressure and vital signs are continuously monitored. Patients with significant comorbidities, abnormal BMI/height/weight ranges, preexisting hypertension, diabetes, anemia, or contraindications to spinal anesthesia are excluded.
Who should consider this trial
Good fit: Ideal candidates are healthy ASA II women with full‑term singleton pregnancies scheduled for elective cesarean under spinal anesthesia who meet the study's height, weight, and BMI limits and have no hypertension, diabetes, or major medical conditions.
Not a fit: Women in active labor, with multiple pregnancies, significant comorbidities (cardiac, renal, cerebrovascular disease), preexisting hypertension or diabetes, extreme BMI, anemia, or contraindications to spinal anesthesia are excluded and would not receive benefit from participation.
Why it matters
Potential benefit: If successful, the results could identify which vasopressor better preserves maternal blood pressure and cardiac output during cesarean, potentially improving maternal stability and fetal safety.
How similar studies have performed: Previous randomized trials comparing vasopressors for cesarean under spinal anesthesia have suggested norepinephrine may better maintain blood pressure with less maternal tachycardia and comparable or improved fetal acid‑base status versus ephedrine, so this approach has supporting evidence but remains actively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists physical status II. * Singleton, full term pregnancy. * Scheduled cesarean delivery under spinal anesthesia. Exclusion Criteria: * 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. * 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.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed M Tawfik, MD
- Email: m2tawfik@mans.edu.eg
- Phone: 0020 1001183400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.