Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine

NCT07322419 | Recruiting Phase 4

• 1 other identifier: MD.25.04.982
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Delivery; Spinal Anesthesia for Cesarean Section

Keywords

Cesarean delivery; Spinal anesthesia; Echocardiography; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection

  From the start of spinal anesthesia until delivery

Secondary Outcomes (12)

• 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

Study Arms (2)

Norepinephrine

EXPERIMENTAL

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

Ephedrine

ACTIVE COMPARATOR

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

Interventions

Spinal Anesthesia with Bupivacaine and Fentanyl PROCEDURE

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

Ephedrine; Norepinephrine

Cesarean Delivery PROCEDURE

Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

Ephedrine; Norepinephrine

Crystalloid Coload 1000 mL DRUG

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

Ephedrine; Norepinephrine

Transthoracic Echocardiography RADIATION

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

Ephedrine; Norepinephrine

Intravenous Norepinephrine Bolus DRUG

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

Norepinephrine

Intravenous Ephedrine Bolus DRUG

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

Ephedrine

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal; Bupivacaine; Fentanyl; Cesarean Section

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Mohamed M Tawfik, MD

CONTACT

0020 1001183400; m2tawfik@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)