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

Not Applicable

Completed

• Conditions: Perioperative Infusion; Ephedrine; Noradrenaline; Cesarean Delivery; Spinal Anesthesia
• Interventions: Drug: Ephedrine; Drug: Noradrenaline

• Registration Number: NCT07067944
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-06
• Study First Submitted QC: 2025-07-06
• Last Update Submitted: 2025-07-06
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Ephedrine	The parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min.
Group B	Noradrenaline	The parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of needed rescue boluses of vasopressors	After induction of spinal anesthesia (Up to 2 hours)	Number of needed rescue boluses of vasopressors to keep hemodynamic stability after spinal anesthesia induction.
Heart rate	Intraoperatively	Intraoperative heart rate was recorded after spinal anesthesia induction.
Incidence of adverse events	2 hours after induction of spinal anesthesia	Incidence of adverse events such as nausea and vomiting were recorded.
APGAR score	5 minutes after delivery	APGAR score was recorded at 1 and 5 minutes after delivery.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt