Comparing Norepinephrine and Ephedrine for Managing Low Blood Pressure During Cesarean Sections
Management of Postspinal Anesthesia Hypotension During Elective Cesarean Section: Baby Norepinephrine Versus Ephedrine
This study is testing whether diluted norepinephrine works better than ephedrine to help keep blood pressure stable during cesarean sections for pregnant women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Hopital Charles Nicolle Academic / other |
| Locations | 1 site (Tunis) |
| Trial ID | NCT06498076 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of diluted norepinephrine compared to ephedrine in managing hypotension that can occur after spinal anesthesia during elective cesarean sections. Spinal anesthesia is preferred for its safety benefits, but hypotension is a common complication that can affect both mother and baby. The study will be conducted as a prospective randomized double-blind trial at Charles Nicolle Hospital, involving consenting full-term pregnant women scheduled for cesarean delivery. The aim is to determine which vasopressor better maintains maternal blood pressure while minimizing adverse effects.
Who should consider this trial
Good fit: Ideal candidates are singleton full-term pregnant women aged 18-38 years, classified as ASA grade II, scheduled for elective cesarean sections under spinal anesthesia.
Not a fit: Patients with ASA grade III or IV, contraindications to spinal anesthesia, or significant comorbidities such as preeclampsia or cardiovascular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve maternal and neonatal outcomes by providing a safer method for managing hypotension during cesarean sections.
How similar studies have performed: Previous studies have explored the use of various vasopressors for managing hypotension during anesthesia, but the specific comparison of diluted norepinephrine and ephedrine in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton full-term consenting pregnant females of ASA grade II, aged 18-38 years, scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria: * Any parturient falling in the category ASA grade III and IV, contrindications to spinal anesthesia, preeclampsia, chronic hypertension, comorbidity with diabetes mellitus, cardiovascular disorders and psychiatric illness are non included. They are excluded the case of failure of spinal anesthesia, conversion to general anesthesia, post-partum bleeding, and failure to follow protocol.
Where this trial is running
Tunis
- Charles Nicolle Hospital — Tunis, Tunisia (Recruiting)
Study contacts
- Study coordinator: Abdelmajid Hafyene, MD
- Email: haf.abdelmajid@gmail.com
- Phone: +216 23252706
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.