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Идёт набор NCT07435337

Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy

Фаза IV С лечением Laryngoscopy Hemodynamic Changes

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: Nalbuphine, Fentanyl.
Кому может быть актуально
Состояния в реестре: Laryngoscopy, Hemodynamic Changes. Базовые параметры: 40 лет — 60 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
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 OF HEMODYNAMIC EFFECTS OF NALBUPHINE VERSUS FENTANYL: A RANDOMIZED, DOUBLE-BLINDED INTERVENTIONAL STUDY IN PATIENTS ON CARDIOPULMONARY BYPASS AT RAWALPINDI INSTITUTE OF CARDIOLOGY, RAWALPINDI

Обзор

Participants will undergo routine pre-operative evaluation. An intravenous line will be placed in the recovery area. On arrival in the operating room, standard monitoring (blood pressure, heart rate, oxygen saturation, ECG, breathing monitor, and temperature) will be applied. A central venous catheter and an arterial line will be inserted under local anesthesia using sterile technique. Before anesthesia induction, patients will receive premedication including midazolam and an opioid pain-relief injection given slowly through the vein. General anesthesia will then be induced with etomidate. After adequate sedation, a muscle relaxant (atracurium) will be administered, and the patient will be ventilated with 100% oxygen using a face mask. The breathing tube will then be inserted and correct placement confirmed. During surgery, anesthesia will be maintained with oxygen, sevoflurane gas, and a continuous atracurium infusion. Hemodynamic parameters such as heart rate and blood pressure will be monitored throughout the peri-intubation and intraoperative period.

Подробное описание

Participants will undergo standard preoperative assessment and will receive oral alprazolam 0.5 mg the night before surgery. Intravenous access will be established in the recovery area. Upon arrival in the operating room, standard monitoring will be applied, including non-invasive blood pressure, pulse oximetry, electrocardiography, capnography, and temperature monitoring. Under aseptic conditions and local anesthesia, a central venous catheter will be inserted into the internal jugular vein and an arterial line into the radial artery.

Premedication with intravenous midazolam 0.01 mg/kg will be administered and baseline parameters recorded. An opioid analgesic (nalbuphine 0.2 mg/kg or fentanyl 3 µg/kg) will be given intravenously over 5 minutes prior to induction of anesthesia. General anesthesia will be induced with intravenous etomidate 0.3 mg/kg. After adequate sedation, atracurium 0.5 mg/kg will be administered to facilitate neuromuscular blockade, followed by bag-mask ventilation with 100% oxygen. Endotracheal intubation will then be performed under direct laryngoscopy, with confirmation of bilateral air entry and secure fixation of the tube.

Anesthesia will be maintained with 60% oxygen in air, sevoflurane (approximately 2 MAC), and a continuous atracurium infusion (5-12 µg/kg/min). Hemodynamic parameters including heart rate and arterial blood pressure will be continuously monitored during the peri-intubation and intraoperative period.

Вмешательства

  • Препарат Nalbuphine
    IV Nalbuphine at dose of 0.2 mg/kg will be given 5 minutes before induction of anesthesia
  • Препарат Fentanyl
    3 Microgram per kilogram body weight IV Fentanyl will be given 5 minutes before induction of anesthesia

Первичные конечные точки

  • Heart Rate [Срок оценки: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation]
  • Systolic Blood Pressure [Срок оценки: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation]
  • Diastolic Blood Pressure [Срок оценки: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation]
  • Mean Blood Pressure [Срок оценки: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation]

Критерии участия

Критерии включения

  • Weighing 40-70kg
  • ASA III of either sex
  • Undergoing cardiac surgery with CPB

Критерии исключения

  • History of Drug Allergy • Pre-existing Asthma • Renal or Hepatic dysfunction • Extreme obesity • Pregnant / lactating patients • Difficult intubation/prolonged intubation

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
  • Deparment of Anesthesia, Rawalpindi Institute of Cardiology, Rawalpindi — Rawalpindi

Публикации

  • Saiyed A, Sharma S, Hussain A. Comparison of analgesic and hemodynamic effects of nalbuphine versus fentanyl: a randomized, double-blinded interventional study in patients on cardiopulmonary bypass. Egypt J Cardiothorac Anesth. 2020;14(2):44.

Идентификаторы

NCT: NCT07435337 · RIC/RERC/29/26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗