Compare two norepinephrine doses to prevent low blood pressure after spinal anesthesia for C-section
The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section
NA · Assiut University · NCT06102382
This study will see if two different infusion rates of norepinephrine can prevent low blood pressure in women having a planned cesarean delivery with spinal anesthesia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 40 Years |
| Sex | Female |
| Sponsor | Assiut University (other) |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06102382 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study compares two prophylactic norepinephrine infusion rates given around the time of spinal anesthesia for planned cesarean delivery. Eligible term pregnant women without major cardiac disease, hypertensive disorders, severe obesity, or contraindications to spinal anesthesia will receive one of the two norepinephrine regimens during the operation. Maternal blood pressure, need for rescue vasopressors, and common side effects such as nausea, bradycardia, or hypertension will be recorded and compared between groups. The goal is to identify which infusion rate better prevents post-spinal hypotension with acceptable safety.
Who should consider this trial
Good fit: Pregnant women at term (≥37 weeks) scheduled for elective cesarean under spinal anesthesia who do not have cardiac disease, hypertensive disorders of pregnancy, severe obesity, or contraindications to spinal anesthesia.
Not a fit: Women with cardiac morbidities, hypertensive pregnancy disorders, severe obesity (BMI ≥40), significant prepartum hemorrhage, or those who decline spinal anesthesia would not be candidates and are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the preferred norepinephrine dose could reduce episodes of maternal low blood pressure during cesarean delivery and decrease the need for rescue medications and associated symptoms.
How similar studies have performed: Previous small studies and clinical reports have shown promising results with norepinephrine for preventing post-spinal hypotension, but the optimal prophylactic dose has not been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women scheduled for cesarean section under spinal anesthesia * Gestational age of at least 37 weeks Exclusion Criteria: * Patient refusal * Contraindications of spinal anesthesia * Allergy to the study drug * Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2. * patients with cardiac morbidities * Hypertensive disorders of pregnancy. * Prepartum hemorrhage
Where this trial is running
Asyut
- Assiut University Woman Health Hospital — Asyut, Egypt (RECRUITING)
Study contacts
- Study coordinator: Zakaria A. Zakaria
- Email: za6841924@gmail.com
- Phone: +201150637566
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.
Conditions: Cesarean Section, Hypotension, Norepinephrine, Spinal anesthesia, Cesarean section