Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Esketamine, Remimazolam, Esketamine and remimazolam, normal saline.
- Кому может быть актуально
- Состояния в реестре: Sleep Disturbance. Базовые параметры: 20 лет — 65 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
- Китай
- 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
Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies
Обзор
To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies
Подробное описание
Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.
Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration.Esketamine is an NMDA receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance and anxiety is worth exploring.
Вмешательства
- Препарат Esketamine
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began - Препарат Remimazolam
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began - Препарат Esketamine and remimazolam
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began - Препарат normal saline
Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began
Первичные конечные точки
- Sleep disturbance and anxiety after surgery [Срок оценки: 1 day before surgery, 1 and 3 days after surgery]
Вторичные конечные точки (12)
- Pain Score (NRS) [Срок оценки: 1 and 3 days after surgery]
- Incidence of injection pain [Срок оценки: Intraoperative]
- Dosage of drug [Срок оценки: Intraoperative]
- Mean intraoperative blood pressure [Срок оценки: Intraoperative]
- Oxygen saturation [Срок оценки: Intraoperative]
- Somatokinetic reaction [Срок оценки: Intraoperative]
- Operation time [Срок оценки: Intraoperative]
- Duration of anesthesia [Срок оценки: After surgery]
- Time of awakening [Срок оценки: After surgery]
- Time to walking down [Срок оценки: After surgery]
- Adverse event [Срок оценки: Within 3 days after surgery]
- Exhaust time [Срок оценки: Within 3 days after surgery]
Критерии участия
Критерии включения
- Age 20-65 years old;
- ASA classification is grade I-III;
- Elective surgery is proposed
- BMI of 19-30 kg/m2;
- Patients who agreed to enroll in this study voluntarily
Критерии исключения
- Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
- Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery;
- ASA rating of IV or V;
- Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
- History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
- Respiratory insufficiency, respiratory failure;
- Patients who refused to use intravenous PCA for analgesia;
- Pregnant or lactating women;
- BMI<18 kg/m2 or BMI>30kg/m2;
- Poor compliance, unable to complete the experiment according to the study plan;
- Participants who have participated in clinical trials of other drugs within the last 4 weeks;
- Any circumstances deemed unsuitable for inclusion by the researcher for any reason.
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
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Китай · 1 центр
- Tianjin Medical University General Hospital — Тяньцзинь
Идентификаторы
NCT: NCT06108830 · GWang024