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

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

Study Overview

• Status: Recruiting
• Conditions: Cognition
• Intervention / Treatment: Drug: Remimazolam tosilate; Drug: Propofol; Other: saline solution

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: chen yongming, MD; Phone Number: 13564932181; Email: chelman@outlook.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Yongming Chen
      • Contact: chen yongming, MD; Phone Number: 13564932181; Email: chelman@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam; IV Remimazolam tosilate 0.3mg/kg	Drug: Remimazolam tosilate; IV before procedure; Other Names: experimental
Active Comparator: propofol; IV propofol 1.2~2.5mg/kg	Drug: Propofol; IV before procedure; Other Names: active comparator
Placebo Comparator: saline; IV saline solution 10ml	Other: saline solution; IV before procedure; Other Names: placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Estimated): December 2, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cognition; Colonoscopy; Remimazolam tosilate; Old
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: WanYi（2020-5）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No