Actively Recruiting
Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial
Led by Cairo University · Updated on 2026-03-23
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the effects of adding a low-dose epinephrine bolus before continuous infusion on maternal blood pressure stability during cesarean delivery under spinal anesthesia. It focuses on spinal-induced hypotension, a common issue during cesarean sections, comparing epinephrine's impact to current vasopressors like norepinephrine, phenylephrine, and ephedrine. The study aims to clarify whether this approach improves maternal heart rate and cardiac output balance better than infusion alone. Participants are randomly assigned to one of two groups: one receives a 4 mcg epinephrine bolus immediately after spinal anesthesia followed by a continuous infusion of 0.03 mcg/kg/min; the other group receives only the infusion at the same dose without the initial bolus. The epinephrine infusion is prepared by diluting 3000 mcg in 500 mL saline, with infusion rates adjusted by weight. This phase 3 trial uses a double-blind design to compare these interventions during elective cesarean sections. Women aged 18 to 35 undergoing elective lower segment cesarean sections under spinal anesthesia are monitored for up to 2 hours after spinal anesthesia. Researchers will measure the incidence and severity of post-spinal hypotension, episodes of reactive hypertension and tachycardia, nausea and vomiting during surgery, and total norepinephrine use. Fetal outcomes will be assessed through umbilical artery blood gases and Apgar scores shortly after delivery. Safety and maternal hemodynamic stability are closely observed throughout the procedure.
CONDITIONS
Brief Title
Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 35 years
- Female participants
- American Society of Anesthesiologists (ASA) physical status II
- Scheduled for elective lower segment cesarean section under spinal anesthesia
You will not qualify if you...
- Uncontrolled cardiac conditions such as ejection fraction below 60%, recent myocardial infarction, stroke, transient ischemic attacks, or coronary artery disease
- Poorly controlled hypertensive disorders related to pregnancy
- Peripartum bleeding
- Multiple pregnancies (e.g., twins)
- Coagulation disorders including low platelet count below 100,000/µL, high INR above 1.4, or inherited clotting factor deficiencies
- Baseline systolic blood pressure less than 100 mmHg or greater than 130 mmHg
- Patient refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 hours after spinal anesthesia
Participants receive spinal anesthesia followed by either a low-dose epinephrine bolus then infusion or epinephrine infusion alone to maintain maternal hemodynamic stability during cesarean section.
1 treatment visit (in-person)
Duration - Up to 5 minutes after fetal delivery
Participants are monitored for maternal and fetal outcomes immediately after delivery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Kasr Alaini hospital
Cairo, Egypt
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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