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

Not Applicable

Not yet recruiting

• Conditions: Hypotension; Cesarean Section; Norepinephrine
• Interventions: Drug: Norepinephrine (0.075); Drug: Norepinephrine (0.1)

• Registration Number: NCT06102382
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-21
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-26
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Study Start: 2023-12-10
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norepinephrine (0.075)	Norepinephrine (0.075)	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.
Norepinephrine (0.1)	Norepinephrine (0.1)	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.

Primary Outcome Measures

Name	Time	Method
The frequency of post-spinal hypotension	During the first hour after the subarachnoid block

Secondary Outcome Measures

Name	Time	Method
Heart rate	During the first hour after the subarachnoid block
Arterial blood pressure (Systolic, diastolic, and mean)	During the first hour after the subarachnoid block
Doses of atropine and ephedrine	Intraoperative
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score	1, 5, and 10 minutes after delivery	Ranges from 0 (the worst score) to 10 (the best score)