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

Phase 4

Completed

• Conditions: Anesthesia; Cesarean Section Complications; Subarachnoid Block
• Interventions: Drug: Ephedrine 5mg; Drug: Ephedrine 15mg; Drug: Ephedrine 10mg

• Registration Number: NCT05993182
• Lead Sponsor: Aswan University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-15
• Study Start: 2023-08-20
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-I	Ephedrine 5mg	received 5mg of Ephedrine after the first hypotension \[ Base line time or starting point is first hypotension\]
Group-III	Ephedrine 15mg	15mg bolus dose of ephedrine IV after the first hypotension \[ Base line time or starting point is first hypotension\]
Group-II	Ephedrine 10mg	received 10mg of Ephedrine after the first hypotension \[ Base line time or starting point is first hypotension\]

Primary Outcome Measures

Name	Time	Method
Survival analysis or time until an event occurs	Intraoperatively	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)

Secondary Outcome Measures

Name	Time	Method
Starting point or Base line time	Intraoperatively	Starting point or Base line time is a first hypotension
Survival time	Intraoperatively	Free of event(No hypotension) at any time after base line

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt