The Effect of Remimazolam on Postoperative Sleep Quality of Patients Undergoing Gynecological Day Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 260
- 主要终点
- Richard Campbell's Sleep Scale score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Remimazolam Grop
Remimazolam 0.3mg/kg for induction and 0.6-1.0 mg/kg·h for maintenance of anesthesia
干预措施: Remimazolam (Drug)
Propofol Group
Propofol 2 mg/kg for induction and 4-12 mg/kg·h for maintenance of anesthesia
干预措施: Propofol (Drug)
结局指标
主要结局
Richard Campbell's Sleep Scale score
时间窗: The night of the first to third postoperative day
Range: 0 points (optimal sleep) to 10 points (optimal sleep). Direction: The higher the score, the more severe the sleep problem
次要结局
- Blood Pressure(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(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(24 hours after the operation)