Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The average intraoperative power spectral density in the frontal alpha band
研究概览
简要总结
Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the effects of remimazolam on EEG and postoperative cognitive function ，in order to further understand the clinical application of remimazolam.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective surgery under general anesthesia.
- •Age, sex, and weight were not limited.
排除标准
- •Allergic or contraindication to remimazolam/midazolam/remifentanil;
- •Abnormal liver and kidney function; Alcohol abuse;
- •Long-term use of sedative, analgesic or anxiolytic drugs;
- •Hearing and language communication disorders;
- •Complicated with severe cardiovascular lesions or neurological diseases.
研究组 & 干预措施
Remimazolam 1
干预措施: remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia (Drug)
Control
干预措施: control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1 (Drug)
结局指标
主要结局
The average intraoperative power spectral density in the frontal alpha band
时间窗: Preoperatively, During operation，End of operation
EEG data were collected at the beginning of the room admission, and the collection was ended at the end of the operation.
Changes in the score of MMSE
时间窗: The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery
The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery
次要结局
- Changes in IL-6, IL-10, and S100-β levels(The outcome above should be measured the day before surgery and 1，3 days after surgery)
研究者
Zhuan Zhang
Director
Yangzhou University