Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine

Mansoura University

Status and phase: Enrolling; Phase 4

Conditions: Spinal Anesthesia for Cesarean Section; Cesarean Delivery

Treatments: Procedure: Cesarean Delivery; Drug: Intravenous Norepinephrine Bolus; Drug: Intravenous Ephedrine Bolus; Drug: Crystalloid Coload 1000 mL; Radiation: Transthoracic Echocardiography; Procedure: Spinal Anesthesia with Bupivacaine and Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT07322419

MD.25.04.982

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Norepinephrine

Experimental group

Treatment:

Radiation: Transthoracic Echocardiography

Procedure: Spinal Anesthesia with Bupivacaine and Fentanyl

Drug: Crystalloid Coload 1000 mL

Drug: Intravenous Norepinephrine Bolus

Procedure: Cesarean Delivery

Ephedrine

Active Comparator group

Treatment:

Radiation: Transthoracic Echocardiography

Procedure: Spinal Anesthesia with Bupivacaine and Fentanyl

Drug: Crystalloid Coload 1000 mL

Drug: Intravenous Ephedrine Bolus

Procedure: Cesarean Delivery