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

Aswan University

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications; Subarachnoid Block; Anesthesia

Treatments: Drug: Ephedrine 5mg; Drug: Ephedrine 15mg; Drug: Ephedrine 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05993182

669/10/22

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Group-I

Active Comparator group

Description:

received 5mg of Ephedrine after the first hypotension \[ Base line time or starting point is first hypotension\]

Treatment:

Drug: Ephedrine 5mg

Group-II

Active Comparator group

Description:

received 10mg of Ephedrine after the first hypotension \[ Base line time or starting point is first hypotension\]

Treatment:

Drug: Ephedrine 10mg

Group-III

Active Comparator group

Description:

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

Treatment:

Drug: Ephedrine 15mg