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

NCT07480889 | Recruiting Phase 3

• 1 other identifier: MS-572-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Hemodynamic (MAP) Stability

Outcome Measures

Primary Outcomes (1)

• Incidence of post-spinal hypotension

  defined as systolic blood pressure drop \>20% from baseline, measured from block onset until 5 minutes after delivery

  up to 2 hours after spinal anesthesia

Secondary Outcomes (9)

• Incidence of severe post-spinal hypotension

  up to 2 hours after spinal anaesthesia

• Number of hypotensive and severe hypotensive episodes per patient

  up to 2 hours after spinal anaesthesia

• Incidence of reactive hypertension (systolic blood pressure ≥ 120% of baseline)

  up to 2 hours after spinal anaesthesia

• Number of reactive hypertension episodes per patient

  up to 2 hours after spinal anaesthesia

• Incidence of tachycardia (heart rate >130% baseline, not related to hypotension)

  up to 2 hours after spinal anaesthesia

Study Arms (2)

Bolus plus infusion group

ACTIVE COMPARATOR

Drug: Epinephrine (Adrenaline) bolus then infusion

Infusion group

ACTIVE COMPARATOR

Drug: Epinephrine (Adrenaline) infusion

Interventions

Epinephrine (Adrenaline) bolus then infusion DRUG

A 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.

Bolus plus infusion group

Epinephrine (Adrenaline) infusion DRUG

Patients will receive the epinephrine infusion dose of 0.03 mcg/Kg/min (6) immediately without the bolus.

Infusion group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 35 years.
• American Society of Anesthesiologists (ASA) physical status II.
• Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.

You may not qualify if:

• Uncontrolled cardiac morbidities as reduction of ejection fraction\< 60%, History (within 3months) of myocardial infarction, cerebrovascular accident, transient ischemic attacks or coronary artery disease/stents
• Poorly controlled Hypertensive disorders of pregnancy
• Peripartum bleeding
• Multiple pregnancies (e.g., twin gestations)
• Coagulation disorders defined as platelet count \<100,000/μL, INR \>1.4, or known inherited clotting factor deficiency.
• Baseline systolic blood pressure (SBP) \< 100 mmHg or \>130 mmHg
• Refusal of patients.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alaini hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesia

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: March 18, 2026
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

EG (1)