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

NCT05255211 | Recruiting Phase 4

• 1 other identifier: WanYi（2020-5）
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognition

Keywords

Remimazolam tosilate; cognition; Old; Colonoscopy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Remimazolam

EXPERIMENTAL

IV Remimazolam tosilate 0.3mg/kg

Drug: Remimazolam tosilate

propofol

ACTIVE COMPARATOR

IV propofol 1.2\~2.5mg/kg

Drug: Propofol

saline

PLACEBO COMPARATOR

IV saline solution 10ml

Other: saline solution

Interventions

Remimazolam tosilate DRUG

IV before procedure

Also known as: experimental

Remimazolam

Propofol DRUG

IV before procedure

Also known as: active comparator

propofol

saline solution OTHER

IV before procedure

Also known as: placebo comparator

saline

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I\~II
• patients will be treatmented by sedation under colonoscopy
• sign informed consent

You may not qualify if:

• (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

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Yongming Chen

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Interventions

Propofol; Saline Solution

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

chen yongming, MD

CONTACT

13564932181; chelman@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: February 24, 2022
• Study Start: December 2, 2021
• Primary Completion: December 2, 2024
• Study Completion: December 30, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)