Improving Sleep After TKA Using Mirtazapine and Quetiapine
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: Mirtazapine, Quetiapine, Placebo.
- Кому может быть актуально
- Состояния в реестре: Osteo Arthritis Knee, Insomnia. Базовые параметры: от 50 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
- Нидерланды
- 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
Mirtazapine and Quetiapine as Treatment for Postoperative Sleep Disturbance After Fast-track Knee Replacement
Обзор
Use of mirtazapine and quetiapine for improvement of sleep quality after TKA
Подробное описание
Background After knee replacement surgery there is a loss of quantity and quality of sleep. Loss of sleep is associated with increased pain perception. Subsequently, patients use more analgesic medication and it takes them longer to fully recover from surgery. Low doses of the tetracyclic antidepressant mirtazapine and the neuroleptic quetiapine are nowadays off-label prescribed for insomnia and improve length and quality of deep sleep phases. Quetiapine and mirtazapine could improve sleep after knee replacement surgery and improve patient recovery. This placebo-controlled, randomized, double-blind study investigates the effect of quetiapine and mirtazapine on functional recovery after total knee arthroplasty.
Methods This is a prospective, single center, double-blinded randomized controlled trial. 165 patients with knee osteoarthritis scheduled for total knee arthroplasty will be randomly allocated to a low-dose quetiapine (LDQ), a low-dose mirtazapine (LDM) group or a placebo group. Outcomes will be evaluated at baseline, 2, 4, 6 and 12 weeks after surgery. Functional outcome after total knee arthroplasty is measured using a patient related outcome measure through the Oxford Knee Score (OKS). In order to measure postoperative sleep quality, patients will be monitored using the Leeds Sleep evaluation questionnaire (LSEQ). Furthermore, pain is registered using a visual analogue scale (VAS), weekly opioid use is monitored, and general health status is reported through the EQ-5D. Analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models. This trial complies with the SPIRIT guidelines for randomized controlled trials.
Discussion This study will provide clinicians with evidence whether quetiapine contributes to rehabilitation of patients undergoing fast-track knee replacement surgery.
Вмешательства
- Препарат Mirtazapine
Use of 3.75mg mirtazapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 7.5mg mirtazapine. - Препарат Quetiapine
Use of 3.125mg quetiapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 6.25mg mirtazapine. - Препарат Placebo
a gelatinous capsule without an active ingredient
Первичные конечные точки
- Oxford Knee Score (OKS) [Срок оценки: 6 weeks after surgery]
Вторичные конечные точки (8)
- Leeds Sleep Evaluation questionnaire (LSEQ) [Срок оценки: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Visual Analogue Scale (VAS) for fatigue [Срок оценки: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Visual Analogue Scale (VAS) for sleep quality [Срок оценки: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Visual Analogue Scale (VAS) for pain in rest [Срок оценки: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Visual Analogue Scale (VAS) for pain during activity [Срок оценки: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- EuroQol (EQ) 5D [Срок оценки: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Morphine use [Срок оценки: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Oxford knee score [Срок оценки: 1 week before surgery; first day postoperative; 2; 4; 12 weeks after surgery]
Критерии участия
Критерии включения
- Indication for TKA
Критерии исключения
- use of benzodiazepines
- use of anti-depressants
- use of oxycodone
- patients diagnosed with obstructive sleep apnea syndrome, severe respiratory insufficiency, or myasthenia
- a known hypersensitivity to mirtazapine, quetiapine and/or related to the gelatinous (placebo) capsule
- insufficient understanding of the Dutch language.
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 2 центра
- Knowledge Center for Orthopedic Surgery, St. Anna hospital — Geldrop
- St. Anna hospital — Geldrop
Идентификаторы
NCT: NCT04728581 · W021-001