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

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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Anesthesia; Subarachnoid Block
• Intervention / Treatment: Drug: Ephedrine 5mg; Drug: Ephedrine 10mg; Drug: Ephedrine 15mg

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81511
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group-I; received 5mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension]	Drug: Ephedrine 5mg; Patients received 5mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
Active Comparator: Group-II; received 10mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension]	Drug: Ephedrine 10mg; Patients received 10mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
Active Comparator: Group-III; 15mg bolus dose of ephedrine IV after the first hypotension [ Base line time or starting point is first hypotension]	Drug: Ephedrine 15mg; Patients received 15mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Starting point or Base line time	Starting point or Base line time is a first hypotension	Intraoperatively
Survival time	Free of event(No hypotension) at any time after base line	Intraoperatively

Collaborators and Investigators

• Sponsor: Aswan University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: 669/10/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: after the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No