Ephedrine for Reducing Onset Time of Rocurinium in Elderly 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: Ephedrine Hydrochloride 30 mg/ml, Saline (NaCl 0,9 %) (placebo).
- Кому может быть актуально
- Состояния в реестре: Neuromuscular Blockade. Базовые параметры: от 80 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
- Дания
- Следующий шаг
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Официальное название
A Blinded Randomized Study of Ephedrine 0.15 Mg/kg for Reducing Onset Time of Rocuronium 0.6 Mg/kg in Elderly Patients (≥ 80 Years)
Обзор
The aim of this study is to determine the onset time of rocuronium after administration of ephedrine 0.15 mg/kg in patients with age ≥ 80 years. The hypothesis of this study is that ephedrine 0.15 mg/kg provides a shorter onset time compared to placebo (saline).
Подробное описание
Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications. Aging leads to a progressive impairment of organ function and a decline in physiologic reserve and in the elderly patient population, pharmacodynamics and pharmacokinetics of medications administered during anesthesia may be influenced by the age-related reduction in cardiac output, liver function and renal function. Also, the body composition changes with age and elderly have lower total body water and an increase in body fat.
Neuromuscular blocking agents (NMBAs) are administered during anesthesia to facilitate tracheal intubation. However, in elderly patients onset time of standard doses of NMBAs are prolonged, and for 0.6 mg/kg of rocuronium it is prolonged by 50% when comparing elderly with younger adults (median 135 seconds vs 90 seconds). A prolonged onset time of rocuronium may result in prolonged time to tracheal intubation which aims to secure the patients airway and breathing during anesthesia and thereby prevents pulmonary aspiration and hypoxia. It is therefore relevant to investigate measures to reduce onset time of rocuronium in the elderly.
Ephedrine administered in younger adults undergoing general anesthesia has reduced the onset time of rocuronium 0.6 mg/kg. The mechanism behind this is speculated to be an increase in cardiac output.
It is possible to detect onset time of NMBAs with objective neuromuscular monitoring perioperatively by train-of-four (TOF) stimulation at the ulnar nerve. The effect of ephedrine on onset time of rocuronium has not been assessed in elderly patients above 80 years of age.
The possible benefit of this trial is to investigate whether ephedrine 0.15 mg/kg reduces onset time of rocuronium 0.6 mg/kg in the elderly. This may result in a shorter time to tracheal intubation and also establish better intubating conditions. The results may help to detect the optimal method for administering rocuronium to facilitate tracheal intubation in elderly patients.
The investigators hypothesize that ephedrine 0.15 mg/kg will provide a shorter onset time of rocuronium compared to placebo (saline).
Вмешательства
- Препарат Ephedrine Hydrochloride 30 mg/ml
0.15 mg/kg during induction. - Препарат Saline (NaCl 0,9 %) (placebo)
1 ml during induction.
Первичные конечные точки
- Onset time of rocuronium 0.6 mg/kg defined as the time from administration of rocuronium until TOF count of 0. [Срок оценки: Within 1 hour]
Вторичные конечные точки (5)
- Intubating conditions assessed by The Intubation Difficulty Scale (IDS) [Срок оценки: Within 1 hour]
- Intubating conditions assessed by Fuchs-Buder scale [Срок оценки: Within 1 hour]
- Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes after administration of ephedrine or saline) [Срок оценки: Within 15 minutes]
- Change in mean arterial blood pressure from before induction to immediately after intubation [Срок оценки: Within 1 hour]
- Time to TOF 0.9 [Срок оценки: Within 4 hours]
Критерии участия
Критерии включения
- Age ≥ 80
- Scheduled for elective operations under general anesthesia with intubation
- American Society of Anesthesiologists physical status classification (ASA) I to III
- Informed consent
- Read and understand Danish
Критерии исключения
- Known allergy to rocuronium or ephedrine
- Neuromuscular disease that may interfere with neuromuscular data
- Indication for rapid sequence induction
- Daily use of beta-blocking agents
- Known cardiac arrythmia (atrial fibrillation, supraventricular or ventricular)
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
Дания · 2 центра
- Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup — Copenhagen
- Department of Anesthesia, Centre of Head and Orthopedics, 6013 Rigshospitalet — Copenhagen
Идентификаторы
NCT: NCT06681662 · Ephedrine for rocuronium