The Effect of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function
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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Remimazolam, propofol.
- Кому может быть актуально
- Состояния в реестре: Cognitive Functioning, Propofol, Remimazolam, Circadian Rhythm. Базовые параметры: 18 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.
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Официальное название
Effects of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function
Обзор
This study want to observe the effects of remimazolam and propofol for general anesthesia on postoperative rhythm and cognitive function. The observation group was given remimazolam for general anesthesia, and the control group was given propofol for general anesthesia. Both drugs are commonly used as intravenous anesthetics for general anesthesia and have been shown to be safe for use in general anesthesia. The investigators hope can understand the effects of remimazolam and propofol for general anesthesia on rhythm status and cognitive function through this study, further reduce the occurrence of postoperative cognitive function impairment, and enable subjects to better recover.
Подробное описание
Benzodiazepines are one of the most important and commonly used intravenous sedatives in the perioperative period. However, benzodiazepines are often associated with a variety of side effects, including respiratory depression, cardiovascular depression, excessive sedation, delayed recovery, disturbance of consciousness, dizziness and nausea, postoperative delirium, and postoperative cognitive impairment. Remimazolam is a new type of benzodiazepine anesthetic drug. It can be rapidly hydrolyzed into inactive carboxylic acid metabolites by widely existing carboxylesterases in the human body. Therefore, it has the characteristics of fast onset, fast metabolism, little impact on liver and kidney function, and little inhibition of respiratory circulation. However, as a benzodiazepine, remimazolam has little effect on postoperative cognitive function.
Biorhythms are currently a hot topic in medical research. Many organisms, including mammals, have the suprachiasmatic nucleus (SCN), a circadian clock pacemaker located in the hypothalamus, which drives the rhythms of activity and rest, fasting and eating, body temperature and hormones to synchronize to 24 hours. Many anesthetic drugs, such as propofol, dexmedetomidine, and volatile anesthetic drugs such as sevoflurane and desflurane, interfere with the expression of circadian rhythm genes in mammals. For example, the expression of rhythm genes per1 and per2 in supratasmatic nucleus of rats injected with a single dose of propofol is down-regulated, and irregular resting activity rhythm is observed in patients undergoing colonoscopy under anesthesia with propofol. The circadian period of patients undergoing general anesthesia is obviously advanced, and the disturbance of circadian rhythm is an important feature of postoperative sleep disorders. However, sleep disorders can aggravate postoperative delirium and postoperative cognitive dysfunction, and related rhythm genes such as Dbp participate in the plasticity of the hippocampus, so the interference of anesthesia drugs on the biological rhythm of the body may be an important cause of postoperative cognitive dysfunction. Since propofol is commonly used in clinical intravenous anesthesia, this study intends to compare the effects of remimazolam and propofol on patients' activity rest rhythm and their effects on learning and memory functions.
Вмешательства
- Препарат Remimazolam
Remimazolam 6mg/kg/h was pumped intravenously for 2.5 min, Sufentanil 0.5 μg/kg and rocuronium 0.6mg/kg were injected intravenously, and endotracheal intubation was performed 3 minutes later. Remimazolam was then pumped at 1 mg/kg/h, the BIS was kept in the range of 40-60 through general anesthesia, and the remimazolam infusion rate was adjusted (0.5-3 mg/kg/h).If the BIS cannot be maintained at ≤ 60 or there are signs of potential inadequate anesthesia (such as cough, sweating, and patient move - Препарат propofol
Propofol (2-3mg/kg), Sufentanil (0.5μg /kg), rocuronium (0.6mg/kg) were injected intravenously, and endotracheal intubation was performed for 3 minutes. Subsequently, propofol was pumped at 4-10mg/kg/h to maintain the BIS in the range of 40-60.
Первичные конечные точки
- Cognitive function [Срок оценки: 30 minutes after extubation and 24 hours after surgery]
- Cognitive function [Срок оценки: 30 minutes after extubation and 24 hours after surgery]
- Cognitive function [Срок оценки: 30 minutes after extubation and 24 hours after surgery]
- Cognitive function [Срок оценки: 30 minutes after extubation and 24 hours after surgery]
- Cognitive function [Срок оценки: 30 minutes after extubation and 24 hours after surgery]
Вторичные конечные точки (10)
- Patient activity/rest condition [Срок оценки: 30 minutes after extubation and 24 hours after surgery]
- The quality of recovery score [Срок оценки: 24 hours after surgery to complete the QoR-15 score assessment]
- ramsay sedation score [Срок оценки: 30min after extubation to complete the ramsay sedation score assessment]
- Anesthesia adverse events [Срок оценки: during surgery]
- drug-related adverse reactions [Срок оценки: during surgery]
- Use of vasoactive drugs [Срок оценки: during surgery]
- fluid volume [Срок оценки: during surgery]
- Record the time of extubation [Срок оценки: From the end of the surgery to leaving the postoperative recovery room]
- Numerical rating scale 24 hours after surgery [Срок оценки: from 24 hours after surgery to complete the NRS pain assessment]
- Postoperative nausea numerical rating scale [Срок оценки: from 24 hours after surgery to complete the postoperative nausea NRS score]
Критерии участия
Критерии включения
Age 18-65 years old, ASAI-III class, BMI18.5-25kg/m2 Inpatients undergoing laparoscopic cholecystectomy The estimated time of operation is 1.5\~2.5 hours Preoperative brief mental status examination (MMSE) score ≥24 Voluntary participation and signed informed consent
Критерии исключения
Pregnant or lactating women Patients who are allergic to remimazolam or contraindicated Patients who are dependent on or tolerant to opioids or have long-term alcoholism Serious cardiovascular system, respiratory system, liver and kidney diseases History of obstructive sleep apnea mental disorders or neurological diseases Patients who participated in clinical trials of other drugs within the last 3 months The attending physician or researcher considers that there are other circumstances that are not suitable for participation in this study Refuse to participate in the study
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
Китай · 1 центр
- The Second Affiliated Hospital of Chongqing Medical University — Чунцин
Идентификаторы
NCT: NCT06775366 · RPPOCD