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RecruitingPhase 4NCT07322419

Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine

Echocardiographic Evaluation of Cardiac Output During Cesarean Delivery Under Spinal Anesthesia Using Norepinephrine Versus Ephedrine: A Randomized Controlled Trial

Sponsor

Mansoura University

Enrollment

200 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Summary

Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another group.

Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 40 Years

Inclusion Criteria3

  • American Society of Anesthesiologists physical status II.
  • Singleton, full term pregnancy.
  • Scheduled cesarean delivery under spinal anesthesia.

Exclusion Criteria11

  • Height <150 or >180 cm.
  • Weight <60 or >110 kg.
  • Body mass index (BMI) <18.5 or ≥35 kg/m².
  • Women presenting in labor.
  • Any contraindication to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection.
  • Chronic or pregnancy-induced hypertension.
  • Baseline systolic blood pressure >140 mm Hg.
  • Hemoglobin <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.

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Interventions

PROCEDURESpinal Anesthesia with Bupivacaine and Fentanyl

Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace

DRUGCrystalloid Coload 1000 mL

Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection

PROCEDURECesarean Delivery

Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

RADIATIONTransthoracic Echocardiography

Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery

DRUGIntravenous Norepinephrine Bolus

Prophylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively

DRUGIntravenous Ephedrine Bolus

Prophylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively

Locations(1)

Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

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NCT07322419