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

NCT05993182 | Completed Phase 4 DMC

• 1 other identifier: 669/10/22
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia; Cesarean Section Complications; Subarachnoid Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Starting point or Base line time

  Intraoperatively

• Survival time

  Intraoperatively

Study Arms (3)

Group-I

ACTIVE COMPARATOR

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

Drug: Ephedrine 5mg

Group-II

ACTIVE COMPARATOR

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

Drug: Ephedrine 10mg

Group-III

ACTIVE COMPARATOR

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

Drug: Ephedrine 15mg

Interventions

Ephedrine 5mg DRUG

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

Group-I

Ephedrine 10mg DRUG

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

Group-II

Ephedrine 15mg DRUG

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

Group-III

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University

Aswān, 81511, Egypt

Location

MeSH Terms

Interventions

Ephedrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Ayman Mohamady Eldemrdash

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: August 20, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)