Vasopressor Infusion in Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.

Detailed Description
-----------------
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

Official Title
-----------------
Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial

Conditions
-----------------
Cesarean Section Complications, Spinal Anesthesia

Intervention / Treatment
-----------------
* Drug: Phenylephrine
* Drug: Norepinephrine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full term pregnant women scheduled for cesarean section Exclusion Criteria: pre-ecpamsia eclampsia bleeding cardiac dysfuction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phenylephrine<br>Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure | Drug: Phenylephrine<br>* Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.<br>Drug: Bupivacaine<br>* Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg<br>* Other names: Marcaine;|
| Experimental: Norepinephrine<br>Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure | Drug: Norepinephrine<br>* Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.<br>* Other names: noradrenaline;Drug: Bupivacaine<br>* Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg<br>* Other names: Marcaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of post-spinal anesthesia hypotension | Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading | 30 minutes after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of severe post-spinal anesthesia hypotension | Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading | 30 minutes after spinal anesthesia | 
| incidence of severe delivery hypotension | Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading | 10 minutes after delivery | 
| systolic blood pressure | systolic blood pressure measured in mmHg | 2 hours after subarachnoid block | 
| diastolic blood pressure | diastolic blood pressure measured in mmHg | 2 hours after subarachnoid block | 
| heart rate | number of heart beats per minute | 2 hours after subarachnoid block | 
| APGAR score | APGAR score of the fetus | 10 minutes after delivery | 
| incidence of reactive hypertension | Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading | 2 hours after spinal anesthesia |