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Completed

NCT Number: NCT07067944

Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia

This study aimed to compare the effects of prophylactic ephedrine and nor-epinephrine infusion on maternal hemodynamics and neonatal outcomes following spinal anesthesia in cesarean deliveries.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Neuraxial anesthesia for cesarean delivery (CD) has significantly reduced maternal mortality by avoiding Manipulation of the airway, the mother being awake, and promoting early bonding of mother and child, adequate Postoperative analgesia, and quicker maternal recovery.

Systemic vascular resistance decreases as a result of a reduction in sympathetic tone of the arterial circulation, leading to peripheral arterial vasodilation, the extent of which depends on the number of spinal segments involved. Other theories are proposed to explain hypotension during spinal anesthesia, among them: 1)direct depressive circulatory effect of local anesthetics, 2) relative adrenal insufficiency, 3) skeletal muscle paralysis, 4) ascending medullary vasomotor block, and 5) concurrent mechanical respiratory insufficiency. Loss of sympathetic input to the heart, leaving vagal parasympathetic innervations unopposed, and a decrease in cardiac preload are the main reasons for bradycardia during spinal anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age more than 21 years.
  • American Society of Anesthesiologists Physical Status II and III.
  • Full-term singleton pregnant women scheduled for elective cesarean section under spinal anesthesia.

Exclusion criteria

  • Morbid obesity [body mass index (BMI)>40].
  • Diabetes Mellitus.
  • Severe cardiovascular disease.
  • Hypertensive disorders of pregnancy.
  • Chronic kidney disease.
  • Non-assuring fetal status.
  • Peripartum bleeding.

Treatment and study plan

Ephedrine

Drug

The parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min.

Noradrenaline

Drug

The parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute.

Primary outcomes

  1. Maternal systolic blood pressure

    Time frame: 10 minutes after induction of spinal anesthesia

    Maternal systolic blood pressure was recorded 10 minutes after induction of spinal anesthesia.

Secondary outcomes

  1. Heart rate

    Time frame: Intraoperatively

    Intraoperative heart rate was recorded after spinal anesthesia induction.

  2. Number of needed rescue boluses of vasopressors

    Time frame: After induction of spinal anesthesia (Up to 2 hours)

    Number of needed rescue boluses of vasopressors to keep hemodynamic stability after spinal anesthesia induction.

  3. Incidence of adverse events

    Time frame: 2 hours after induction of spinal anesthesia

    Incidence of adverse events such as nausea and vomiting were recorded.

  4. APGAR score

    Time frame: 5 minutes after delivery

    APGAR score was recorded at 1 and 5 minutes after delivery.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Preventive Role of Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized, Prospective Double-blinded Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

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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