Norepinephrine Infusion Different Doses in Cesarean Delivery

Study Overview
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Brief Summary
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three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.

Detailed Description
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Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia). Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.

Official Title
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Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: norepinephrine infusion (0.025 mcg/Kg/min)
* Drug: norepinephrine infusion (0.050 mcg/Kg/min)
* Drug: norepinephrine infusion (0.075 mcg/Kg/min)
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: full term singleton pregnant women scheduled for elective cesarean delivery Exclusion Criteria: cardiac morbidities hypertensive disorders of pregnancy peripartum bleeding baseline systolic blood pressure (SBP) < 100 mmHg body mass index > 35 will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.025 mcg /Kg/min group<br>The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min). | Drug: norepinephrine infusion (0.025 mcg/Kg/min)<br>* The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)<br>* Other names: noradrenaline infusion;Drug: Bupivacaine<br>* The patient will receive spinal anesthesia using Bupivacaine (10 mg).<br>* Other names: Heavy marcaine;|
| Experimental: 0.050 mcg/Kg/min group<br>The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min). | Drug: norepinephrine infusion (0.050 mcg/Kg/min)<br>* The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)<br>* Other names: noradrenaline infusion;Drug: Bupivacaine<br>* The patient will receive spinal anesthesia using Bupivacaine (10 mg).<br>* Other names: Heavy marcaine;|
| Experimental: 0.075 mcg/Kg/min group<br>The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min) | Drug: norepinephrine infusion (0.075 mcg/Kg/min)<br>* The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).<br>* Other names: noradrenaline infusion;Drug: Bupivacaine<br>* The patient will receive spinal anesthesia using Bupivacaine (10 mg).<br>* Other names: Heavy marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postspinal hypotension | The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group | 30 minutes after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe postspinal hypotension | The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group | 30 minutes after spinal anesthesia | 
| Post-delivery hypotension | number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion) | 10 minutes after delivery | 
| systolic blood pressure | systolic blood pressure measured in mmHg | 60 minutes after spinal block | 
| diastolic blood pressure | diastolic blood pressure measured in mmHg | 60 minutes after spinal block | 
| heart rate | heart rate measured in beats per minute | 60 minutes after spinal block | 
| intraoperative hypertension | number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group | 60 minutes after spinal block | 
| incidence of nausea and vomiting | number of patients who develop nausea and vomiting divided by the total number of patients in the group | 60 minutes after spinal block | 
| ephedrine consumption | total amount of ephedrine consumed during the operation (measured in milligrams) | 60 minutes after spinal block | 
| Atropine consumption | total amount of atropine consumed during the operation (measured in milligrams) | 60 minutes after spinal block | 
| APGAR score | APGAR score for detection of the well being of the fetus | 1 minute after delivery | 
| APGAR score | APGAR score for detection of the well being of the fetus | 10 minutes after delivery |