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Completed

NCT Number: NCT05993182

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

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

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aswan University

Aswān, 81511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ephedrine 5mg

Drug

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

Ephedrine 10mg

Drug

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

Ephedrine 15mg

Drug

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

Primary outcomes

  1. Survival analysis or time until an event occurs

    Time frame: 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 outcomes

  1. Starting point or Base line time

    Time frame: Intraoperatively

    Starting point or Base line time is a first hypotension

  2. Survival time

    Time frame: Intraoperatively

    Free of event(No hypotension) at any time after base line

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2023
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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