Investigating the effects of a sedation drug on cognition in elderly patients during colonoscopy
Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
This study is testing whether a sedation drug called Remimazolam affects thinking skills in older patients during a colonoscopy compared to another sedation option.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05255211 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate how Remimazolam tosilate affects cognitive function in elderly patients undergoing colonoscopy. The study compares the cognitive outcomes of patients sedated with Remimazolam to those receiving Propofol and saline solution. By focusing on older adults, the trial seeks to address potential cognitive impairments associated with sedation during medical procedures. Participants will be carefully selected based on specific inclusion and exclusion criteria to ensure the validity of the results.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients classified as ASA I or II who require sedation for a colonoscopy.
Not a fit: Patients with preoperative cognitive impairments, depression, or significant health issues such as severe liver or kidney damage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation practices that minimize cognitive impairment in elderly patients during colonoscopy.
How similar studies have performed: While there is ongoing research into sedation effects on cognition, this specific approach using Remimazolam tosilate in elderly patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai
- Yongming Chen — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: chen yongming, MD
- Email: chelman@outlook.com
- Phone: 13564932181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.