Comparing Norepinephrine and Phenylephrine for Blood Pressure Control During Cesarean Delivery
Manually Controlled Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section: A Double-blinded Randomized Controlled Study
This study is testing whether using norepinephrine instead of phenylephrine can better control blood pressure during cesarean deliveries with spinal anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Hassan II University Academic / other |
| Locations | 2 sites (Fes and 1 other locations) |
| Trial ID | NCT06248593 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of continuous infusion of norepinephrine versus phenylephrine on blood pressure maintenance during spinal anesthesia for elective cesarean sections. It is a randomized, double-blind, two-arm, parallel, non-inferiority trial conducted at Hassan II University Hospital in Fes, Morocco. Participants will receive either norepinephrine or phenylephrine, with infusion rates adjusted based on maternal arterial pressure, to assess differences in neonatal outcomes and maternal hemodynamics.
Who should consider this trial
Good fit: Ideal candidates include full-term, singleton, non-laboring pregnant women scheduled for elective cesarean delivery under spinal anesthesia with stable baseline blood pressure.
Not a fit: Patients with known fetal abnormalities, preexisting hypertension, or contraindications to spinal anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve blood pressure management during cesarean deliveries, leading to better outcomes for both mothers and their newborns.
How similar studies have performed: Previous studies have shown varying results with similar approaches, but this specific comparison of norepinephrine and phenylephrine in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Full-term, singleton, pregnant women, nonlaboring. * Scheduled for elective cesarean delivery under spinal anesthesia, * American Society of Anesthesiologists physical status : 1 or 2 * Baseline systolic BP between 90 and 140 mm Hg. Exclusion Criteria: * Known fetal abnormality. * Preexisting or pregnancy-induced hypertension, cardiovascular, cerebrovascular or kidney disease. * Contraindication to spinal anesthesia. * Peripartum hemorrhage. * Body mass index above 40 kg/m2.
Where this trial is running
Fes and 1 other locations
- University hospital Hassan II — Fes, Morocco (Not_yet_recruiting)
- University hospital Hassan II — Fes, Morocco (Recruiting)
Study contacts
- Principal investigator: Mohamed Adnane Berdai, MD-PhD — University hospital Hassan II, Fes, Morocco
- Study coordinator: Mohamed Adnane Berdai, MD-PhD
- Email: adnane.berdai@yahoo.fr
- Phone: +212655260752
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.