Actively Recruiting

Phase 3
Age: 18Years - 35Years
FEMALE
ID07480889

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

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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