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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07067944
Enrollment
100
Registered
2025-07-16
Start date
2023-07-01
Completion date
2024-03-01
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Infusion, Ephedrine, Noradrenaline, Cesarean Delivery, Spinal Anesthesia

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.

Interventions

DRUGEphedrine

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

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maternal systolic blood pressure10 minutes after induction of spinal anesthesiaMaternal systolic blood pressure was recorded 10 minutes after induction of spinal anesthesia.

Secondary

MeasureTime frameDescription
Heart rateIntraoperativelyIntraoperative heart rate was recorded after spinal anesthesia induction.
Number of needed rescue boluses of vasopressorsAfter induction of spinal anesthesia (Up to 2 hours)Number of needed rescue boluses of vasopressors to keep hemodynamic stability after spinal anesthesia induction.
Incidence of adverse events2 hours after induction of spinal anesthesiaIncidence of adverse events such as nausea and vomiting were recorded.
APGAR score5 minutes after deliveryAPGAR score was recorded at 1 and 5 minutes after delivery.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026