The Effect of Remimazolam on Postoperative Sleep Quality

Официальное название

The Effect of Remimazolam on Postoperative Sleep Quality of Patients Undergoing Gynecological Day Surgery

Обзор

A large amount of clinical evidence shows that after surgery, especially major surgery, the sleep quality of patients often drops significantly immediately, with the most obvious decline on the first night after surgery, which can last for several days to several months. Remimazolam is a new type of benzodiazepine drug and a super-short-acting GABAA receptor agonist. Compared with propofol, remimazolam can largely avoid adverse reactions such as hemodynamic fluctuations, excessive sedation and injection pain caused by propofol. It has good safety and is superior to propofol. However, there are currently only a few clinical research results regarding the impact of remimazolam on the sleep quality of patients under general anesthesia or sedation. Therefore, this study intends to observe the effect of remimazolam on the sleep quality of patients in gynecological day surgery. It is expected that by optimizing the anesthesia plan, the postoperative sleep quality of patients can be improved, and ultimately the postoperative recovery of patients can be promoted.

Вмешательства

• Препарат Remimazolam
  Remimazolam 0.3 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 0.6-1.0 mg/kg·h is used for anesthesia maintenance.
• Препарат Propofol
  Propofol 2 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 4-12 mg/kg·h is used for anesthesia maintenance

Первичные конечные точки

• Richard Campbell's Sleep Scale score [Срок оценки: The night of the first to third postoperative day]

Вторичные конечные точки (3)

• Blood Pressure [Срок оценки: Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed]
• Heart rate [Срок оценки: Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed.]
• Postoperative adverse reactions [Срок оценки: 24 hours after the operation]

Критерии участия

Критерии включения

• ASA classification grades I - II.
• BMI: 18.5-24 kg/m ².
• Be able to correctly understand and complete the assessment scale independently.
• The operation time shall not exceed one hour.
• Informed consent for this research.

Критерии исключения

• PSQI > 7 points (with sleep disorders requiring medical intervention within the last month).
• Suffering from central nervous system diseases or mental disorders.
• Patients with sleep apnea syndrome or other serious respiratory diseases.
• Have functional disorders of important organs.
• Alcohol abuse or a history of opioid, benzodiazepine or other known drug abuse that may affect sleep.
• Allergic to the research medication.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07094945 · 2025S076

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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