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

Sponsor

Aswan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05993182

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

74.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Cesarean Section Complications Subarachnoid Block	Drug: Ephedrine 5mg Drug: Ephedrine 10mg Drug: Ephedrine 15mg	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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]

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]

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 70-89mmHg

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 gestation
fetal malformation
coagulopathies
morbid obesity and spine deformity
profound hypotesion (total spinal ) bradycardia and need atropine and sever bleeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University	Aswan		Egypt	81511

Sponsors and Collaborators

Aswan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayman Mohamady Eldemrdash, Doctor Ayman Mohamady Eldemrdash, Aswan University

ClinicalTrials.gov Identifier:

NCT05993182

Other Study ID Numbers:

669/10/22

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 15, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ephedrine

Pseudoephedrine

Study Results

No Results Posted as of Aug 15, 2023