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

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

Detailed Description
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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.

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

Conditions
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Cesarean Section, Hypotension, Norepinephrine

Intervention / Treatment
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* Drug: Norepinephrine (0.1)
* Drug: Norepinephrine (0.075)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norepinephrine (0.1)<br>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. | Drug: Norepinephrine (0.1)<br>* 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.<br>|
| Active Comparator: Norepinephrine (0.075)<br>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. | Drug: Norepinephrine (0.075)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of post-spinal hypotension |  | During the first hour after the subarachnoid block | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Norepinephrine, Spinal anesthesia, Hypotension, Cesarean section