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

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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Delivery; Spinal Anesthesia for Cesarean Section
• Intervention / Treatment: Drug: Crystalloid Coload 1000 mL; Procedure: Cesarean Delivery; Procedure: Spinal Anesthesia with Bupivacaine and Fentanyl; Radiation: Transthoracic Echocardiography; Drug: Intravenous Norepinephrine Bolus; Drug: Intravenous Ephedrine Bolus

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohamed M Tawfik, MD; Phone Number: 0020 1001183400; Email: m2tawfik@mans.edu.eg

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35511
      • Recruiting
      • Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals
      • Contact: Mohamed M Tawfik, MD; Phone Number: 0020 1001183400; Email: m2tawfik@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ephedrine	Drug: Crystalloid Coload 1000 mL; Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection; Procedure: Cesarean Delivery; Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization; Procedure: Spinal 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; Radiation: Transthoracic 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; Drug: Intravenous 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
Experimental: Norepinephrine	Drug: Crystalloid Coload 1000 mL; Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection; Procedure: Cesarean Delivery; Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization; Procedure: Spinal 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; Radiation: Transthoracic 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; Drug: Intravenous 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection	From the start of spinal anesthesia until delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery		From the start of spinal anesthesia until delivery
Differences between the 2 groups in stroke volume at 1 and 10 minutes after intrathecal injection, and after delivery		From the start of spinal anesthesia until delivery
Differences between the 2 groups in heart rate at 1 and 10 minutes after intrathecal injection, and after delivery		From the start of spinal anesthesia until delivery
Differences between the 2 groups in mean arterial pressure at 1 and 10 minutes after intrathecal injection, and after delivery		From the start of spinal anesthesia until delivery
Differences between the 2 groups in systemic vascular resistance at 1 and10 minutes after intrathecal injection, and after delivery		From the start of spinal anesthesia until delivery
Number of patients receiving rescue vasopressor	Systolic blood pressure <90% of baseline value	From the start of spinal anesthesia until delivery
Incidence of hypotension	Systolic blood pressure <80% of baseline value	From the start of spinal anesthesia until delivery
Incidence of severe hypotension	Systolic blood pressure <70% of baseline value	From the start of spinal anesthesia until delivery
Incidence of bradycardia	Heart rate <50 beats/min	From the start of spinal anesthesia until delivery
Incidence of nausea and/or vomiting		From the start of spinal anesthesia until delivery
Total vasopressor dose		From the start of spinal anesthesia until delivery
Neonatal Apgar score at 1 and 5 minutes after delivery	Scale from 0 to 10. Higher scores mean better outcomes.	1 and 5 minutes after delivery

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Echocardiography; Hemodynamics; Cesarean delivery
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Surgical Procedures, Operative; Anilides; Amides; Aniline Compounds; Amines; Piperidines; Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Delivery, Obstetric; Obstetric Surgical Procedures; Bupivacaine; Fentanyl; Anesthesia, Spinal; Cesarean Section
• Other Study ID Numbers: MD.25.04.982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be provided to the Publishing journal if requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No