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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05993182
• Other study ID #: 669/10/22
• Status: Completed
• Phase: Phase 4
• Start date: August 20, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Aswan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cesarean Section Complications
• Subarachnoid Block

Intervention

Drug:
• Ephedrine 5mg
Patients received 5mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
• Ephedrine 10mg
Patients received 10mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
• Ephedrine 15mg
Patients received 15mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Starting point or Base line time	Starting point or Base line time is a first hypotension	Intraoperatively
Secondary	Survival time	Free of event(No hypotension) at any time after base line	Intraoperatively