Actively Recruiting

Phase 4
Age: 19Years - 40Years
FEMALE
ID07322419

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

Age: 19Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • American Society of Anesthesiologists physical status II
  • Singleton, full term pregnancy
  • Scheduled cesarean delivery under spinal anesthesia
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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