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

Tanta University

Status: Completed

Conditions: Noradrenaline; Ephedrine; Spinal Anesthesia; Cesarean Delivery; Perioperative Infusion

Treatments: Drug: Noradrenaline; Drug: Ephedrine

Study type: Interventional

Funder types: Other

Identifiers

NCT07067944

36264MS146/4/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: Ephedrine

Group B

Experimental group

Description:

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

Treatment:

Drug: Noradrenaline