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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05255211
Enrollment
90
Registered
2022-02-24
Start date
2021-12-02
Completion date
2024-12-30
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition

Keywords

Remimazolam tosilate, cognition, Old, Colonoscopy

Brief summary

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

Interventions

DRUGRemimazolam tosilate

IV before procedure

DRUGPropofol

IV before procedure

OTHERsaline solution

IV before procedure

Sponsors

Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mini-mental State Examination(MMSE) score 15 minutes before procedureThe 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>=4The 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;

Countries

China

Contacts

Primary Contactchen yongming, MD
chelman@outlook.com13564932181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026