Actively Recruiting

Phase 3
Age: 18Years - 35Years
FEMALE
NCT07480889

Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section

Led by Cairo University · Updated on 2026-03-23

100

Participants Needed

1

Research Sites

10 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In North America, norepinephrine, ephedrine, and epinephrine have been recommended as first-choice vasopressors for the treatment of spinal hypotension during cesarean delivery. However, in international consensus guidelines, epinephrine was recommended for circulatory collapse only. Phenylephrine infusion is an important therapeutic strategy for preventing spinal-induced hypotension (SIH) in cesarean delivery, as it decreases the incidence of hypotension, nausea, and vomiting. However, high doses may reduce maternal heart rate and cardiac output in a dose-dependent manner. Ephedrine, previously considered the first-choice drug, has both α and β receptor agonistic activity and causes norepinephrine release from sympathetic neurons. Its β1 effect increases heart rate and contractility, but may cause undesirable tachycardia. Tachyphylaxis can develop with repeated doses. Norepinephrine, the biosynthetic precursor of epinephrine, has both potent α and weak β agonist effects, tending to cause bradycardia. Despite a lower incidence of hypotension with prophylactic norepinephrine, PSH still occurs in up to 30% of parturients undergoing cesarean section. The administration of a bolus dose of epinephrine prior to continuous infusion is an unusual practice in obstetric anesthesia, but has been reported to be safe in other contexts and in pregnant women when used for hemodynamic support. Epinephrine has both potent α- and β-adrenoceptor agonist activity. Its β effects could offset reflex decreases in maternal HR and CO during spinal anesthesia for cesarean delivery. Although some studies compared epinephrine infusion with phenylephrine, it remains unclear whether adding an initial bolus of epinephrine before infusion offers superior maternal hemodynamic stability compared to infusion alone.

CONDITIONS

Official 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
  • American Society of Anesthesiologists (ASA) physical status II
  • Undergoing 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 attack, or coronary artery disease/stents within 3 months
  • Poorly controlled hypertensive disorders during pregnancy
  • Peripartum bleeding
  • Multiple pregnancies (e.g., twins)
  • Coagulation disorders including platelet count below 100,000/µL, INR above 1.4, or known inherited clotting deficiencies
  • Baseline systolic blood pressure less than 100 mmHg or greater than 130 mmHg
  • Patient refusal to participate

AI-Screening

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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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Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section | DecenTrialz