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NCT Number: NCT07480889

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alaini hospital

Cairo, Egypt

Location status: Recruiting

Location contact

Dina A Turki, MD of anesthesia

PRINCIPAL_INVESTIGATOR

abdelkhalek m Samy

CONTACT

[email protected]

01025854248

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Epinephrine (Adrenaline) infusion

Drug

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

Primary outcomes

  1. Incidence of post-spinal hypotension

    Time frame: up to 2 hours after spinal anesthesia

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

Secondary outcomes

  1. Incidence of severe post-spinal hypotension

    Time frame: up to 2 hours after spinal anaesthesia

    systolic blood pressure drop >30% from baseline or systolic blood pressure<80 mmHg

  2. Number of hypotensive and severe hypotensive episodes per patient

    Time frame: up to 2 hours after spinal anaesthesia

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

    Time frame: up to 2 hours after spinal anaesthesia

  4. Number of reactive hypertension episodes per patient

    Time frame: up to 2 hours after spinal anaesthesia

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

    Time frame: up to 2 hours after spinal anaesthesia

  6. Incidence of intraoperative nausea and vomiting

    Time frame: up to 2 hours after spinal anesthesia

  7. Total intraoperative norepinephrine consumption

    Time frame: up to 2 hours after spinal anaesthesia

  8. Fetal outcomes: umbilical artery blood gases

    Time frame: up to 5 minutes after fetal delivery

    Umbilical artery blood gases obtained after delivery at 1 and 5 minutes

  9. • Fetal outcomes: Apgar scores

    Time frame: up to 5 minutes after delivery

    Apgar scores at 1 and 5 minutes after delivery

    Appearance (Skin color: 0=Blue/Pale, 1=Pink body/blue limbs, 2=All pink) Pulse (Heart rate: 0=None, 1=<100 bpm, 2=>100 bpm) Grimace (Reflex irritability: 0=None, 1=Grimace, 2=Cry/vigorous reaction) Activity (Muscle tone: 0=Limp, 1=Some flexion, 2=Active motion) Respiration (Breathing: 0=None, 1=Weak/irregular, 2=Strong cry)

    Interpretation:

    7-10: Normal (reassuring). 4-6: Fair/Abnormal (may require stimulations or oxygen). 0-3: Low/Critically low (indicates need for intensive resuscitation).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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