Actively Recruiting
Echocardiographic Evaluation of Cardiac Output During Cesarean Delivery Under Spinal Anesthesia Using Norepinephrine Versus Ephedrine: A Randomized Controlled Trial
Led by Mansoura University · Updated on 2026-01-14
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of two different vasopressor drugs, norepinephrine and ephedrine, on heart function during cesarean delivery under spinal anesthesia in healthy women with full-term singleton pregnancies. The study uses echocardiography to measure cardiac output and other hemodynamic variables, comparing the responses between the two drug groups. The trial is a randomized controlled study conducted by Mansoura University, focusing on key heart and blood pressure measurements during surgery. Participants receive spinal anesthesia using bupivacaine and fentanyl, followed by a crystalloid fluid infusion. They are randomly assigned to receive either intravenous norepinephrine or ephedrine boluses immediately after spinal anesthesia. Additional doses are given if blood pressure drops below set thresholds. Cesarean delivery is performed using a standard surgical technique, and heart function is monitored through transthoracic echocardiography at specific time points before and after delivery. Women in the study are closely monitored from the start of spinal anesthesia until delivery, with repeated heart rate, blood pressure, and cardiac output assessments. Researchers record episodes of low blood pressure, heart rate changes, and the need for additional vasopressors. Newborns' health is assessed by Apgar scores at 1 and 5 minutes after birth. The trial lasts through the cesarean delivery procedure, with detailed safety and effectiveness data collected during this period.
CONDITIONS
Brief Title
Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologists physical status II
- Singleton, full term pregnancy
- Scheduled cesarean delivery under spinal anesthesia
You will not qualify if you...
- Height less than 150 cm or greater than 180 cm
- Weight less than 60 kg or greater than 110 kg
- Body mass index less than 18.5 or equal to or greater than 35 kg/m2
- Women presenting in labor
- Any contraindication to spinal anesthesia such as increased intracranial pressure, coagulopathy, or local skin infection
- Chronic or pregnancy-induced hypertension
- Baseline systolic blood pressure greater than 140 mm Hg
- Hemoglobin less than 10 g/dl
- Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
- Polyhydramnios or known significant fetal abnormalities
- Current administration of vasoactive drugs such as beta blockers, salbutamol, or thyroxin
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From the start of spinal anesthesia until delivery
Participants undergo cesarean delivery under spinal anesthesia. They receive spinal anesthesia with bupivacaine and fentanyl, a crystalloid coload, and either prophylactic norepinephrine or ephedrine boluses. Cardiac output and other heart function measurements are taken before, during, and after the spinal anesthesia until delivery.
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt, 35511
Actively Recruiting
Research Team
M
Mohamed M Tawfik, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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