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

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255211
• Other study ID #: WanYi(2020-5)
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: RenJi Hospital
• Contact: chen yongming, MD
• Phone: 13564932181
• Email: chelman[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition

Intervention

Drug:
• Remimazolam tosilate
IV before procedure
• Propofol
IV before procedure

Other:
• saline solution
IV before procedure

Locations

Country	Name	City	State
China	Yongming Chen	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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