Clinical trial

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

NCT05993182

Name

669/10/22

Description

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

Trial arms

Trial start

2023-08-20

Estimated PCD

2024-01-01

Trial end

2024-01-01

Status

Completed

Phase

Early phase I

Treatment

Ephedrine 5mg

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

Arms:

Group-I

Ephedrine 10mg

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

Arms:

Group-II

Ephedrine 15mg

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

Arms:

Group-III

Size

300

Primary endpoint

Survival analysis or time until an event occurs

Intraoperatively

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}

Updated at

2024-03-01

1 organization

1 product

3 indications

Organization

Aswan University

Product

Ephedrine

Indication

Anesthesia

Indication

Cesarean Section Complications

Indication

Subarachnoid Block