Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy

Study Overview
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Brief Summary
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To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy

Official Title
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Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy

Conditions
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Cognition

Intervention / Treatment
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* Drug: Remimazolam tosilate
* Drug: Propofol
* Other: saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I II patients will be treatmented by sedation under colonoscopy sign informed consent 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br>IV Remimazolam tosilate 0.3mg/kg | Drug: Remimazolam tosilate<br>* IV before procedure<br>* Other names: experimental;|
| Active Comparator: propofol<br>IV propofol 1.2 2.5mg/kg | Drug: Propofol<br>* IV before procedure<br>* Other names: active comparator;|
| Placebo Comparator: saline<br>IV saline solution 10ml | Other: saline solution<br>* IV before procedure<br>* Other names: placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remimazolam tosilate, cognition, Old, Colonoscopy