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Идёт набор NCT06836986

COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES for PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION-A Double Blind Randomized Controlled Trial

Без фазы С лечением Spinal Anesthesia Induced Hypotension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Norepinephrine Bolus, Phenylephrine bolus.
Кому может быть актуально
Состояния в реестре: Spinal Anesthesia Induced Hypotension. Базовые параметры: 18 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES FOR PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION- A Double Blind Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. The main questions it aims to answer are: Does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? We will compare effectiveness of norepinephrine and phenylephrine for the prevention of spinal anesthesia induced hypotension. Participants will: Be administered prophylactic boluses of both drugs right after spinal anesthesia induction and maternal hemodynamic parameters and neonatal APGAR scores will be recorded

Подробное описание

Spinal anesthesia is a common mode of anesthesia in cesarean delivery. Spinal anesthesia induced hypotension is one of the most common complication that can affect both mother and fetus. For the management of spinal anesthesia induced hypotension, preloading with crystalloids and colloids, use on ionotropic agents and vasopressors have already been in practice.

Objective of this study is to compare efficacy of prophylactic use of norepinephrine and phenylephrine bolus dosage for spinal anesthesia induced hypotension.

This study is being conducted at the department of anesthesiology ,K.M Pfau civil hospital, Dow university of health sciences, Karachi , Pakistan. Data is being collected after taking approval from Institutional review board and written informed consent from the participants.

Participants are being enrolled by primary investigator. All participants are undergoing simple randomization by lottery method.

After enrollment of participants, demographic data, hemodynamic parameters and other relevant details are being recorded till delivery of the neonate.

Hemodynamic parameters that are heart rate, systolic and diastolic blood pressure, mean arterial blood pressure is being recorded every 3mins. APGAR scoring of neonate is also being recorded.

After completion of data collection, data will be done using Statistical package for social sciences 26.

Вмешательства

  • Препарат Norepinephrine Bolus
    Prophylactic norepinephrine bolus of 8 micrograms will be administered right after spinal anesthesia induction. Rescue bolus of norepinephrine 4 micrograms will be administered in case of hypotension.
  • Препарат Phenylephrine bolus
    Prophylactic phenylephrine bolus of 100 micrograms will be administered right after spinal anesthesia induction. Rescue bolus of phenylephrine 50 micrograms will be administered in case of hypotension.

Первичные конечные точки

  • Incidence of spinal anesthesia induced Hypotension [Срок оценки: From induction of spinal anesthesia till delivery of neonate]

Критерии участия

Критерии включения

  • American society of anesthesiologists II and III patients
  • Age 18-40years
  • Gestational age 32 weeks and above

Критерии исключения

  • Patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 99 mmHg.
  • Baseline mean arterial pressure less than 70 mmHg.
  • Antepartum hemorrhage/intraoperative blood loss greater than 1000ml
  • history indicative of cardiovascular or neurological disease.
  • known fetal abnormality.
  • Patients taking serotonin reuptake inhibitor, Tricyclic antidepressants,monoamine oxidase inhibitors.
  • Maternal situations requiring immediate administration of general anesthesia

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Пакистан · 1 центр
  • Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of an — Karachi

Публикации

  • Nadella H, Islam A, Ina EA, Levin D, Bacoat-Jones T. The Management of Spinal and Epidural Anesthesia-Related Hypotension in the United States During Cesarean Childbirth. Cureus. 2024 Mar 17;16(3):e56340. doi: 10.7759/cureus.56340. eCollection 2024 Mar. PMID 38633922
  • Ng K, Parsons J, Cyna AM, Middleton P. Spinal versus epidural anaesthesia for caesarean section. Cochrane Database Syst Rev. 2004;2004(2):CD003765. doi: 10.1002/14651858.CD003765.pub2. PMID 15106218

Идентификаторы

NCT: NCT06836986 · spinal induced hypotension

Первоисточники (государственные реестры)

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