beta
Trial Radar AI
Clinical Trial NCT07480889 for Hemodynamic (MAP) Stability is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section Phase 3 100 International Pregnancy

Recruiting
Clinical Trial NCT07480889 is designed to study Treatment for Hemodynamic (MAP) Stability. It is a Phase 3 interventional study that is recruiting, having started on 18 March 2026, with plans to enroll 100 participants. Led by Cairo University, it is expected to complete by 1 June 2026. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
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...Show More
Official 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

Conditions
Hemodynamic (MAP) Stability
Other Study IDs
  • MS-572-2025
NCT ID Number
NCT07480889
Start Date (Actual)
2026-03-18
Last Update Posted
2026-03-23
Completion Date (Estimated)
2026-06
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorBolus plus infusion group
Epinephrine (Adrenaline) bolus then infusion
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.
Active ComparatorInfusion group
Epinephrine (Adrenaline) infusion
Patients will receive the epinephrine infusion dose of 0.03 mcg/Kg/min (6) immediately without the bolus.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of severe post-spinal hypotension
systolic blood pressure drop \>30% from baseline or systolic blood pressure\<80 mmHg
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
Incidence of intraoperative nausea and vomiting
up to 2 hours after spinal anesthesia
Total intraoperative norepinephrine consumption
up to 2 hours after spinal anaesthesia
Fetal outcomes: umbilical artery blood gases
Umbilical artery blood gases obtained after delivery at 1 and 5 minutes
up to 5 minutes after fetal delivery
• Fetal outcomes: Apgar scores
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).
up to 5 minutes after delivery
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
  1. Age: 18 to 35 years.
  2. American Society of Anesthesiologists (ASA) physical status II.
  3. Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.

  1. 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
  2. Poorly controlled Hypertensive disorders of pregnancy
  3. Peripartum bleeding
  4. Multiple pregnancies (e.g., twin gestations)
  5. Coagulation disorders defined as platelet count <100,000/μL, INR >1.4, or known inherited clotting factor deficiency.
  6. Baseline systolic blood pressure (SBP) < 100 mmHg or >130 mmHg
  7. Refusal of patients.
Cairo University logoCairo University1117 active studies to explore
Study Responsible Party
AbdElKhalik Mahmoud Shaban, Principal Investigator, Lecturer of anaesthesia, Cairo University
No contact data.
1 Study Locations in 1 Countries
Kasr Alaini hospital, Cairo, Egypt
abdelkhalek m Samy, Contact, 01025854248, [email protected]
Dina A Turki, MD of anesthesia, Principal Investigator
Recruiting