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

Aswan University300 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Anesthesia Cesarean Section Complications Subarachnoid Block

Interventions

Ephedrine 5mgDRUG

Patients received 5mg bolus dose of ephedrine Intravenous after the first hypotension \[ Base line time or starting point is first hypotension\]

Ephedrine 10mgDRUG

Patients received 10mg bolus dose of ephedrine Intravenous after the first hypotension \[ Base line time or starting point is first hypotension\]

Ephedrine 15mgDRUG

Patients received 15mg bolus dose of ephedrine Intravenous after the first hypotension \[ Base line time or starting point is first hypotension\]

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Aswan University

Aswān, Egypt

Outcomes

Primary Outcomes

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)

Time frame: Intraoperatively

Secondary Outcomes

Starting point or Base line time

Starting point or Base line time is a first hypotension

Time frame: Intraoperatively

Survival time

Free of event(No hypotension) at any time after base line

Time frame: Intraoperatively

Data from ClinicalTrials.gov

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