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| Name | Class |
|---|---|
| Shanghai Jiao Tong University School of Medicine | OTHER |
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To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental | IV Remimazolam tosilate 0.3mg/kg |
|
| propofol | Active Comparator | IV propofol 1.2~2.5mg/kg |
|
| saline | Placebo Comparator | IV saline solution 10ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam tosilate | Drug | IV before procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mini-mental State Examination(MMSE) score 1 | 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; | 5 minutes before procedure |
| Mini-mental State Examination(MMSE) score 2 | 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; | 30 minutes after colonoscopy when VAAS score>=4 |
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Inclusion Criteria:
Exclusion Criteria:
(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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chen yongming, MD | Contact | 13564932181 | chelman@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongming Chen | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | IV before procedure |
|
|
| saline solution | Other | IV before procedure |
|
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |