Adding a low-dose epinephrine bolus before infusion to stabilize maternal blood pressure 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
This test will see if giving a small epinephrine bolus before a continuous epinephrine infusion prevents low blood pressure in healthy women having an elective cesarean under spinal anesthesia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07480889 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional study compares two epinephrine strategies during elective spinal cesarean delivery: a low-dose bolus given immediately before starting a continuous epinephrine infusion versus infusion alone. The protocol monitors maternal mean arterial pressure, heart rate, symptoms like nausea and vomiting, and basic neonatal outcomes such as Apgar scores. Eligible participants are ASA II women aged 18–35 undergoing lower-segment cesarean section at Kasr Alaini Hospital, with exclusions for significant cardiac disease, multiple pregnancy, coagulopathy, poorly controlled hypertension, or active peripartum bleeding. Investigators will record hemodynamic variables before and after spinal anesthesia and compare the incidence and severity of spinal-induced hypotension and related interventions between the two groups.
Who should consider this trial
Good fit: Healthy pregnant women aged 18–35 with ASA physical status II scheduled for elective lower-segment cesarean delivery under spinal anesthesia who do not have major cardiac disease, multiple pregnancy, coagulopathy, uncontrolled hypertension, or active peripartum bleeding.
Not a fit: Women with significant cardiac disease, poorly controlled hypertensive disorders, multiple gestations, coagulation abnormalities, active peripartum bleeding, baseline systolic blood pressure outside 100–130 mmHg, or who refuse participation are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce episodes of low blood pressure and related symptoms during cesarean delivery while preserving maternal heart rate and cardiac output.
How similar studies have performed: Phenylephrine and norepinephrine infusion strategies have shown benefit in preventing spinal-induced hypotension, but using a pre-infusion low-dose epinephrine bolus is relatively novel and has limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Where this trial is running
Cairo
- Kasr Alaini hospital — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.