Comparison of Two Different Doses of Phenylephrine on Oxytocin Hemodynamic Effect

Официальное название

Effects of Two Different Doses of Phenylephrine co Administration on Oxytocin- Induced Hemodynamic Effects

Обзор

Cesarean section is one of the commonly performed surgical procedures in the world. Once baby is delivered during the surgical procedure anesthesiologist administer Oxytocin drug through IV cannula which helps the Uterus to contract so that excessive blood loss doesnt occur. But this is associated with fall in blood pressure frequently requiring administration of medications to treat low blood pressure. The most frequently used drug is phenylephrine which can administered along with oxytocin to prevent fall in blood pressure. This study will compare to different doses of Phenylephrine to prevent fall in blood pressure.

Подробное описание

Cesarean section is one of the most commonly performed surgical procedures worldwide. Following delivery of the neonate, oxytocin is routinely administered intravenously to promote uterine contraction and thereby reduce the risk of postpartum hemorrhage. However, oxytocin administration is frequently associated with maternal hypotension, which may necessitate pharmacological intervention. Phenylephrine, a selective α-adrenergic agonist, is commonly used to prevent or treat oxytocin-induced hypotension due to its vasoconstrictive properties. The optimal prophylactic dose of phenylephrine administered concurrently with oxytocin remains uncertain. This study aims to compare two different doses of phenylephrine for the prevention of hypotension following oxytocin administration during cesarean section.

Вмешательства

• Препарат Phenylephrine bolus 75 micrograms
  After delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 75 micrograms of Phenylephrine Intravenously.
• Препарат Phenylephrine bolus 50 micrograms
  After delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 50 micrograms of Phenylephrine Intravenously.

Первичные конечные точки

• Number of Hypotensive episodes [Срок оценки: Number of hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine]

Вторичные конечные точки (1)

• Rescue Phenylephrine consumed [Срок оценки: This will be the total amount of Phenylephrine consumed to treat the hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine]

Критерии участия

Критерии включения

\- Females having a singleton pregnancy Patients planned for elective cesarean section under spinal anesthesia

Критерии исключения

• Patients having a placental abnormality

• Patients taking beta-blocker and vasodilator therapy
• Patients with hypertensive disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• Department of Anesthesia, Holy Family Hospital, Rawalpindi — Rawalpindi

Публикации

• Sharma N, Agarwal S, Modi YC, Yadav A, Yadav J, Sindhi R, et al. Effect of Two Different Doses of Intravenous Phenylephrine on the Prevention of Oxytocin Induced Hypotension in Lower Segment Caesarean Section Under Subarachnoid Block: A Randomised Controlled Study. J Clin Diagn Res. 2023;17(9):16-21.

Идентификаторы

NCT: NCT07420127 · 781/IREF/RMU/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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