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

Phase 4
Recruiting
Conditions
Cognition
Interventions
Registration Number
NCT05255211
Lead Sponsor
RenJi Hospital
Brief Summary

To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
90
Inclusion Criteria
  1. ASA I~II
  2. patients will be treatmented by sedation under colonoscopy
  3. 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RemimazolamRemimazolam tosilateIV Remimazolam tosilate 0.3mg/kg
propofolPropofolIV propofol 1.2\~2.5mg/kg
salinesaline solutionIV saline solution 10ml
Primary Outcome Measures
NameTimeMethod
Mini-mental State Examination(MMSE) score 15 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 230 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;

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yongming Chen

🇨🇳

Shanghai, Shanghai, China

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