Back to resultsEffect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
Primary Purpose
Cognition
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Remimazolam tosilate
Propofol
saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Cognition focused on measuring Remimazolam tosilate, cognition, Old, Colonoscopy
Eligibility Criteria
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
Sites / Locations
- Yongming ChenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Remimazolam
propofol
saline
Arm Description
IV Remimazolam tosilate 0.3mg/kg
IV propofol 1.2~2.5mg/kg
IV saline solution 10ml
Outcomes
Primary Outcome Measures
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;
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;
Secondary Outcome Measures
Full Information
NCT ID
NCT05255211
First Posted
December 2, 2021
Last Updated
February 15, 2022
Sponsor
RenJi Hospital
Collaborators
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05255211
Brief Title
Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
Official Title
Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
December 2, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition
Keywords
Remimazolam tosilate, cognition, Old, Colonoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam
Arm Type
Experimental
Arm Description
IV Remimazolam tosilate 0.3mg/kg
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
IV propofol 1.2~2.5mg/kg
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
IV saline solution 10ml
Intervention Type
Drug
Intervention Name(s)
Remimazolam tosilate
Other Intervention Name(s)
experimental
Intervention Description
IV before procedure
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
active comparator
Intervention Description
IV before procedure
Intervention Type
Other
Intervention Name(s)
saline solution
Other Intervention Name(s)
placebo comparator
Intervention Description
IV before procedure
Primary Outcome Measure Information:
Title
Mini-mental State Examination(MMSE) score 1
Description
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;
Time Frame
5 minutes before procedure
Title
Mini-mental State Examination(MMSE) score 2
Description
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;
Time Frame
30 minutes after colonoscopy when VAAS score>=4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chen yongming, MD
Phone
13564932181
Email
chelman@outlook.com
Facility Information:
Facility Name
Yongming Chen
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chen yongming, MD
Phone
13564932181
Email
chelman@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
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