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Norepinephrine Infusion vs Bolus vs Ephedrine for Blood Pressure Stability During Cesarean Delivery in Women With Preeclampsia
Sponsor: Benha University
Summary
This randomized controlled trial will compare norepinephrine infusion, norepinephrine bolus, and ephedrine bolus for maintaining hemodynamic stability during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Eighty-four eligible women will be randomly allocated in a 1:1:1 ratio to one of three treatment groups. The primary outcome is hemodynamic control during the first 20 minutes after spinal anesthesia, including the occurrence of hypotension, need for rescue vasopressors, and maintenance of blood pressure within ±20% of baseline. Secondary outcomes include severe hypotension, time to first hypotensive episode, vasopressor requirements, maternal adverse effects, fluid balance, and neonatal outcomes including Apgar scores, umbilical cord blood gases, and NICU admission.
Official title: Norepinephrine Infusion Versus Bolus for Sustained Hemodynamic Stability in Preeclamptic Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2025-07-18
Completion Date
2026-07-18
Last Updated
2026-09-30
Healthy Volunteers
No
Interventions
Norepinephrine (0.05 μg/kg/min)
Participants will receive a prophylactic intravenous norepinephrine infusion at 0.05 µg/kg/min, started immediately after spinal injection and titrated by ±0.02 µg/kg/min every 2 minutes to maintain systolic blood pressure at or above 80% of baseline. If hypotension persists despite two vasopressor doses or infusion adjustments, the infusion rate may be increased by 0.02-0.05 µg/kg/min according to the study rescue protocol.
Norepinephrine 4mcg
Participants will receive intravenous norepinephrine 4 µg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 2 minutes as needed. If hypotension persists after two vasopressor doses, the norepinephrine bolus may be escalated to 6 µg according to the study rescue protocol.
Ephedrine Bolus 6 mg
Participants will receive intravenous ephedrine 6 mg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 3 minutes as needed. If hypotension persists after two vasopressor doses, the ephedrine bolus may be escalated to 10 mg according to the study rescue protocol.
Locations (1)
Benha University Hospital
Banhā, Egypt