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NCT Number: NCT07322419

Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine

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.

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Key information

Conditions

Cesarean Delivery Spinal Anesthesia for Cesarean Section

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location status: Recruiting

Location contact

Mohamed M Tawfik, MD

CONTACT

[email protected]

0020 1001183400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Crystalloid Coload 1000 mL

Drug

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

Cesarean Delivery

Procedure

Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

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

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

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

Primary outcomes

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

    Time frame: From the start of spinal anesthesia until delivery

Secondary outcomes

  1. Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery

    Time frame: From the start of spinal anesthesia until delivery

  2. Differences between the 2 groups in stroke volume at 1 and 10 minutes after intrathecal injection, and after delivery

    Time frame: From the start of spinal anesthesia until delivery

  3. Differences between the 2 groups in heart rate at 1 and 10 minutes after intrathecal injection, and after delivery

    Time frame: From the start of spinal anesthesia until delivery

  4. Differences between the 2 groups in mean arterial pressure at 1 and 10 minutes after intrathecal injection, and after delivery

    Time frame: From the start of spinal anesthesia until delivery

  5. Differences between the 2 groups in systemic vascular resistance at 1 and10 minutes after intrathecal injection, and after delivery

    Time frame: From the start of spinal anesthesia until delivery

  6. Number of patients receiving rescue vasopressor

    Time frame: From the start of spinal anesthesia until delivery

    Systolic blood pressure <90% of baseline value

  7. Incidence of hypotension

    Time frame: From the start of spinal anesthesia until delivery

    Systolic blood pressure <80% of baseline value

  8. Incidence of severe hypotension

    Time frame: From the start of spinal anesthesia until delivery

    Systolic blood pressure <70% of baseline value

  9. Incidence of bradycardia

    Time frame: From the start of spinal anesthesia until delivery

    Heart rate <50 beats/min

  10. Incidence of nausea and/or vomiting

    Time frame: From the start of spinal anesthesia until delivery

  11. Total vasopressor dose

    Time frame: From the start of spinal anesthesia until delivery

  12. Neonatal Apgar score at 1 and 5 minutes after delivery

    Time frame: 1 and 5 minutes after delivery

    Scale from 0 to 10. Higher scores mean better outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed M Tawfik, MD

CONTACT

[email protected]

0020 1001183400

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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