CognitionPhase 4NCT05255211
Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
A Phase 4 study testing Remimazolam tosilate, Propofol and saline solution in people with Cognition, run by RenJi Hospital at 1 site in China.
Trial summary
To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognition
- What is being tested?
- Remimazolam tosilate, Propofol and saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2021to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I~II
- patients will be treatmented by sedation under colonoscopy
- sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yongming Chen
Shanghai, Shanghai Municipality, 200127
chen yongming, MD, 13564932181, chelman@outlook.com
About this study
To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam tosilateDrug
Also called experimental
IV before procedure
PropofolDrug
Also called active comparator
IV before procedure
saline solutionOther
Also called placebo comparator
IV before procedure
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | IV Remimazolam tosilate 0.3mg/kg Receives: Drug: Remimazolam tosilate |
| propofol | Active comparator | IV propofol 1.2~2.5mg/kg Receives: Drug: Propofol |
| saline | Placebo comparator | IV saline solution 10ml Receives: Other: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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;
Measured: 30 minutes after colonoscopy when VAAS score>=4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start2 Dec 2021
- Primary completion2 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255211
- Sponsor's protocol ID
- WanYi（2020-5）
- Status last verified
- Mar 2024
- First submitted
- 2 Dec 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Early Cognition Under Sedation by Rimazole Toluenesulfonate in Old Patient Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT05255211
- Acronym / sponsor ID
- WanYi（2020-5）
- Conditions
- Cognition
- Keywords
- Remimazolam tosilate, cognition, Old, Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 2 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect on cognition under sedation by Rimazole toluenesulfonatein elderly patients undergoing colonoscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam tosilateIV Remimazolam tosilate 0.3mg/kg |
| propofol | Active comparator | Drug: PropofolIV propofol 1.2~2.5mg/kg |
| saline | Placebo comparator | Other: saline solutionIV saline solution 10ml |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I~II
- patients will be treatmented by sedation under colonoscopy
- sign informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam tosilateAlso: experimentalIV before procedure | Drug | Remimazolam |
| PropofolAlso: active comparatorIV before procedure | Drug | propofol |
| saline solutionAlso: placebo comparatorIV before procedure | Other | saline |
Primary outcome
Mini-mental State Examination(MMSE) score 1
Time frame: 5 minutes before procedure
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;
Mini-mental State Examination(MMSE) score 2
Time frame: 30 minutes after colonoscopy when VAAS score>=4
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;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam tosilate, Propofol and saline solution in people with Cognition, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chen yongming, MD (13564932181, chelman@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-mental State Examination(MMSE) score 1 (time frame: 5 minutes before procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.