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Идёт набор NCT07662408

Comparison of Norepinehrine Versus Phenylepherine Infusion for Prevention of Post-spinal Hypotension

Фаза IV С лечением Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia Orthopedic Hip Sugery in Eldely Patients

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, Phenylephrine.
Кому может быть актуально
Состояния в реестре: Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia, Orthopedic Hip Sugery in Eldely Patients. Базовые параметры: 60 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

Comparison of Norepinephrine Versus Phenylephrine Infusion for Prevention of Hypotension Due to Subarachnoid Block in Elderly Patients Undergoing Orthopedic Hip Surgery:A Prospective Randomized Trial

Обзор

This prospective randomized double-blinded clinical trial aims to compare the efficacy and hemodynamic effects of prophylactic norepinephrine infusion versus phenylephrine infusion for prevention of spinal anesthesia-induced hypotension in elderly patients undergoing elective orthopedic hip surgery under subarachnoid block. Sixty-two patients aged 60 years or older will be randomly assigned into two equal groups to receive either norepinephrine infusion (8 µg/min) or phenylephrine infusion (100 µg/min) immediately after spinal anesthesia. The primary outcome is the mean heart rate during vasopressor infusion, while secondary outcomes include incidence of hypotension, severe hypotension, bradycardia, reactive hypertension, intraoperative fluid requirements, blood loss, transfusion requirements, and postoperative nausea and vomiting. Hemodynamic parameters will be monitored throughout surgery to evaluate the safety and effectiveness of both vasopressor strategies.

Подробное описание

Spinal anesthesia-induced hypotension is a common and clinically significant complication in elderly patients undergoing orthopedic hip surgery. Age-related physiological changes, impaired autonomic responses, and reduced cardiovascular reserve increase susceptibility to hypotension after subarachnoid block, which may result in organ hypoperfusion, myocardial ischemia, nausea, vomiting, and increased perioperative morbidity.

Phenylephrine is traditionally used for prevention and treatment of spinal anesthesia-induced hypotension because of its potent alpha-adrenergic vasoconstrictive effect. However, its use may be associated with reflex bradycardia and reduction in cardiac output. Norepinephrine, which possesses both alpha-adrenergic and mild beta-adrenergic activity, may provide better maintenance of heart rate and cardiac output while effectively preserving blood pressure.

This prospective randomized double-blinded clinical trial will be conducted at the Department of Anesthesia, Intensive Care and Pain Management, Sohag University Hospitals, after approval from the Institutional Ethics Committee. Elderly patients aged 60 years or older, classified as ASA physical status I-III and scheduled for elective orthopedic hip surgery under spinal anesthesia, will be enrolled after obtaining written informed consent.

Вмешательства

  • Препарат Norepinephrine
    norepinephrine infusion at 8 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.
  • Препарат Phenylephrine
    phenylephrine infusion at 100 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.

Первичные конечные точки

  • Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring [Срок оценки: From the start of subarachnoid block until the end of surgery .]
Вторичные конечные точки (5)
  • Incidence of spinal anesthesia-induced hypotension [Срок оценки: From the administration of spinal anesthesia until the end of the procedure.]
  • Incidence of bradycardia [Срок оценки: Throughout the intraoperative period]
  • Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring [Срок оценки: Every 5 minutes from the start of spinal anesthesia until the end of surgery.]
  • Incidence of reactive hypertension measured by non-invasive blood pressure monitoring [Срок оценки: From the start of vasopressor infusion until the end of surgery.]
  • Total intraoperative intavenous fluid [Срок оценки: At the end of the surgical procedure.]

Критерии участия

Критерии включения

  • Age 60 years or older.
  • ASA physical status I-III.
  • Scheduled for elective hip surgery under subarachnoid block.
  • Willing to provide written informed consent.

Критерии исключения

  • Patient refusal.
  • Contraindications to subarachnoid block.
  • Severe cardiac disease.
  • Uncontrolled hypertension.
  • Allergy to study drugs.
  • Emergency surgery.
  • Monoamine oxidase inhibitor use.
  • Cognitive impairment preventing informed consent.

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

Египет · 1 центр
  • Sohag university hospital — Sohag

Идентификаторы

NCT: NCT07662408 · Soh-Med-26-5-9MS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗