The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section

Assiut University

Status: Enrolling

Conditions: Hypotension; Cesarean Section; Norepinephrine

Treatments: Drug: Norepinephrine (0.075); Drug: Norepinephrine (0.1)

Study type: Interventional

Funder types: Other

Identifiers

NCT06102382

Noradrenaline in CS under SA

Details and patient eligibility

About

To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Full description

Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine.

Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity.

Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose.

The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Enrollment: 100 estimated patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women scheduled for cesarean section under spinal anesthesia
• Gestational age of at least 37 weeks

Exclusion criteria

• Patient refusal
• Contraindications of spinal anesthesia
• Allergy to the study drug
• Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
• patients with cardiac morbidities
• Hypertensive disorders of pregnancy.
• Prepartum hemorrhage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Norepinephrine (0.1)

Experimental group

Description:

An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.

Treatment:

Drug: Norepinephrine (0.1)

Norepinephrine (0.075)

Active Comparator group

Description:

An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.

Treatment:

Drug: Norepinephrine (0.075)