Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block.

Study Overview
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Brief Summary
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compare the time of second hypotension after administration of three different doses of ephedrine 5,10,15 mg

Detailed Description
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In cesarean section, under subarachnoid block the most common complication is hypotension with a reported incidence greater than 80%. Hypotension may occur even after left uterine displacement and preloading with crystalloid. The severity of hypotension depends on the degree of aortocaval compression syndrome, the amount of crystalloid preloading, doses of local anesthetic drugs administered. The most effective treatment of hypotension associated with cesarean section under subarachnoid block is the administration of vasopressor drugs.

Official Title
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Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block - Time to Event Analysis.

Conditions
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Anesthesia, Cesarean Section Complications, Subarachnoid Block

Intervention / Treatment
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* Drug: Ephedrine 5mg
* Drug: Ephedrine 10mg
* Drug: Ephedrine 15mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists 1 and 2 patients Gestational amenorrhea of > 32 weeks Elective cesarean section Patient willing for spinal anesthesia. Singleton pregnancy with cephalic presentation. Baseline systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 70-89 mmHg. Exclusion Criteria: Any contraindication to spinal anesthesia, i.e., local infection at the site of injection valvular heat diseases bleeding tendency any co-morbidity like diabetes mellitus liver cirrhosis renal failure any obstetric complications like placenta previa pregnancy-induced hypertension or HELLP syndrome multiple gestations fetal malformation coagulopathies morbid obesity and spine deformity profound hypotension (total spinal) bradycardia and need atropine and severe bleeding

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group-I<br>received 5mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension] | Drug: Ephedrine 5mg<br>* Patients received 5mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]<br>|
| Active Comparator: Group-II<br>received 10mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension] | Drug: Ephedrine 10mg<br>* Patients received 10mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]<br>|
| Active Comparator: Group-III<br>15mg bolus dose of ephedrine IV after the first hypotension [ Base line time or starting point is first hypotension] | Drug: Ephedrine 15mg<br>* Patients received 15mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival analysis or time until an event occurs | The study time is a30 minute and blood pressure is measured automatically non invasive at 3-minute intervals. If systolic blood pressure decreased more than 20% from the baseline(Event) | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Starting point or Base line time | Starting point or Base line time is a first hypotension | Intraoperatively | 
| Survival time | Free of event(No hypotension) at any time after base line | Intraoperatively |