Two-channel IV-PCA With Dexmedetomidine
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: Dexmedetomidine, Control.
- Кому может быть актуально
- Состояния в реестре: Analgesia, Patient-Controlled, Dexmedetomidine. Базовые параметры: от 20 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
- South Korea
- 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
Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery
Обзор
Dexmedetomidine was administered in the 'selector' channel and fentanyl in the 'basic \& bolus' channel of dual channel intravenous patient-controlled analgesia (IV-PCA) and the amount of opioid consumption was compared. In addition, intensity of pain, postoperative nausea/vomiting, and postoperative delirium was evaluated.
Подробное описание
Bellomic® (Cebika, Uiwang-si, Gyeonggi-do, South Korea), a new IV-PCA device consisting of two separate drug pump channels, can be used in various ways and is expanding its scope of use. Unlike conventional IV-PCA devices, which have been used to mix and administer all drugs in one channel, the device can inject drugs separately in two channels. One channel (Selector \& Bolus) allows the patient to control whether to take additional bolus medication by pressing the button with adjustable continuous infusion, while the other channel (Continuous) allows constant rate continuous infusion.
Dexmedetomidine is a selective alpha-2 agonist, which is widely used in intensive care unit management, surgery, and various procedures because it has the advantage of less respiratory suppression along with sedation/anesthesia and pain effects. It has been previously reported that postoperative pain, morphine usage, and nausea/vomiting can be reduced when used during/after surgery in addition to general anesthetic drugs. However, in terms of major abdominal surgery, there is no research related to the use of dexmedetomidine after surgery, even though a large amount of opioid agents are required due to severe acute pain.
Thus, the investigators planned a randomized controlled trial to investigate the effectiveness dexmedetomidine using dual-chamber IV-PCA.
Вмешательства
- Препарат Dexmedetomidine
Dexmedetomidine 0.2mcg/kg/hr (2ml/hr) administration via continuous channel in the experimental group - Препарат Control
Normal saline 2ml/hr administration via continuous channel in the experimental group
Первичные конечные точки
- Fentanyl consumption during 24 hours [Срок оценки: 24 hours after surgery]
Вторичные конечные точки (7)
- Additional analgesic consumption at post-anesthesia care unit [Срок оценки: 1 hour after surgery]
- Fentanyl consumption during 1,6,48 hours [Срок оценки: 1,6,24,48 hours after surgery]
- Pain scores at 1,6,24,48 hours [Срок оценки: 1,6,24,48 hours after surgery]
- Rescue analgesic consumption at 1,6,24,48 hours [Срок оценки: 1,6,24,48 hours after surgery]
- Adverse events during 1,6,24,48 hours [Срок оценки: 1,6,24,48 hours after surgery]
- Delirium during 1,6,24,48 hours [Срок оценки: 1,6,24,48 hours after surgery]
- Satisfaction score at 24 hours [Срок оценки: 24 hours after surgery]
Критерии участия
Критерии включения
- Patients who was scheduled for laparoscopic major abdominal surgery (Gastrectomy, Hepatectomy, Colectomy, Pancreatectomy) under general anesthesia
- Aged ≥ 20 years old
Критерии исключения
- Body mass index ≥35 kg/m2
- American Society of Anesthesiologists physical status > 3
- Severe cardiovascular disorder
- Severe liver or renal dysfunction
- Preoperative dyspnea
- Contraindication to dexmedetomidine (preoperative severe bradycardia (Heart rate <50), atrioventricular block, allergy to dexmedetomidine)
- Preoperative use of opioid, anticonvulsant, antidepressant
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
South Korea · 1 центр
- Korea University Guro Hospital — Seoul
Идентификаторы
NCT: NCT05672225 · 2022GR0414