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RecruitingNCT07480889

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

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

Summary

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

Interventions

TypeNameDescription
DRUGEpinephrine (Adrenaline) bolus then infusionA bolus of 4 mcg epinephrine will be given just after spinal anaesthesia followed by 0.03 mcg/kg/min infusion which is equivalent to 1.8 mcg/kg/hr. Epinephrine dose of 3000 mcg will be diluting in 500 mL saline (6 mcg/mL), and the infusion rate will be set on 0.3 mL/kg/hr.
DRUGEpinephrine (Adrenaline) infusionPatients will receive the epinephrine infusion dose of 0.03 mcg/Kg/min (6) immediately without the bolus.

Timeline

Start date
2026-03-18
Primary completion
2026-05-01
Completion
2026-06-01
First posted
2026-03-18
Last updated
2026-03-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07480889. Inclusion in this directory is not an endorsement.