Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mini-mental State Examination(MMSE) score 1
研究概览
简要总结
To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients will be treatmented by sedation under colonoscopy
- •sign informed consent
排除标准
- •(1) Preoperative depression and cognitive impairment
- •（2） Hearing or visual impairment;
- •（3） Drug abuse, alcoholism or long-term use of antidepressants;
- •（4） Cardiovascular and cerebrovascular accidents, neurological sequelae, or severe liver and kidney function damage occurred within 6 months
- •（5） BMI < 18, BMI > 30
- •（6） Confirmed or suspected allergy to the test drug
研究组 & 干预措施
Remimazolam
IV Remimazolam tosilate 0.3mg/kg
干预措施: Remimazolam tosilate (Drug)
propofol
IV propofol 1.2~2.5mg/kg
干预措施: Propofol (Drug)
saline
IV saline solution 10ml
干预措施: saline solution (Other)
结局指标
主要结局
Mini-mental State Examination(MMSE) score 1
时间窗: 5 minutes before procedure
The MMSE scoring standard is the preferred scale for dementia screening. It can comprehensively, accurately and quickly reflect the mental state and cognitive defects of the subjects.The values is 0\~30. Cognitive dysfunction: the highest score is 30 points, the score is normal at 27-30, and the score \<27 is cognitive dysfunction; Dementia classification criteria: illiteracy ≤ 17, primary school level ≤ 20, secondary school level (including technical secondary school) ≤ 22 points, university level (including junior college) ≤ 23 points; 3. Dementia severity classification: mild MMSE ≥21 points; moderate, MMSE 10-20 points; severe, MMSE ≤9 points;
Mini-mental State Examination(MMSE) score 2
时间窗: 30 minutes after colonoscopy when VAAS score>=4
The MMSE scoring standard is the preferred scale for dementia screening. It can comprehensively, accurately and quickly reflect the mental state and cognitive defects of the subjects.The values is 0\~30. Cognitive dysfunction: the highest score is 30 points, the score is normal at 27-30, and the score \<27 is cognitive dysfunction; Dementia classification criteria: illiteracy ≤ 17, primary school level ≤ 20, secondary school level (including technical secondary school) ≤ 22 points, university level (including junior college) ≤ 23 points; 3. Dementia severity classification: mild MMSE ≥21 points; moderate, MMSE 10-20 points; severe, MMSE ≤9 points;
次要结局
未报告次要终点