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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05993182
Enrollment
300
Registered
2023-08-15
Start date
2023-08-20
Completion date
2024-01-01
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Cesarean Section Complications, Subarachnoid Block

Brief summary

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

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.

Interventions

DRUGEphedrine 5mg

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

DRUGEphedrine 10mg

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

DRUGEphedrine 15mg

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

Sponsors

Aswan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Survival analysis or time until an event occursIntraoperativelyThe 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

MeasureTime frameDescription
Starting point or Base line timeIntraoperativelyStarting point or Base line time is a first hypotension
Survival timeIntraoperativelyFree of event(No hypotension) at any time after base line

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026