Gastroscopic and Colonoscopic SedationNCT05254366
A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
An observational study of Gastroscopic and Colonoscopic Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 19 sites in China.
Trial summary
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastroscopic and Colonoscopic Sedation
- What is being tested?
- Remimazolam Tosilate for Injection
- Type of treatment
- Injection or infusion
- How many people
- 2,022 participants
- Where
- 19 sitesChina
- Study dates
- 30 Jan 2022to 8 Feb 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients receiving remazolam toluenesulfonate for painless gastroscopy and colonoscopy
Who may be able to join
- Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
- Patients need to sign informed consent
Who cannot join
- Patients who are participating in or planning to participate in any interventional clinical trial
- The investigator considers that there are any other reasons for the patient's ineligibility for the study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Binzhou Medical University Hospital
Binzhou, Shandong, 256600
Hunan Provincial People's Hospital and The First Affiliated Hospital of Hunan Normal University
Changsha, Hunan, 410005
Changshu No.2 People's Hospital (Affiliated Changshu Hospital of Nantong University)
Changshu, Jiangsu, 215500
The People's Hospital of Chizhou
Chizhou, Anhui, 247000
Dazhou Central Hospital
Dazhou, Sichaun, 63500
Shengli Oilfield Central Hospital
Dongying, Guangxi, 257034
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250012
Leshan People's Hospital
Leshan, Sichuan, 614000
Linyi People's Hospital
Linyi, Shandong, 276000
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Suqian People's Hospital of Nanjing Drum Tower Hospital Group
Suqian, Jiangsu, 223800
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600
Tianjin Nankai Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, 300100
Wuhan Central Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430014
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
About this study
Official title: A Domestic, Prospective, Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained
- Conditions
- Gastroscopic and Colonoscopic Sedation
- Being tested
- Remimazolam Tosilate for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam Tosilate for InjectionDrug
Remimazolam Tosilate for Injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Painless gastroscopic sedation cohort Receives: Drug: Remimazolam Tosilate for Injection | |
| Cohort 2 | Painless colonoscopy sedation cohort Receives: Drug: Remimazolam Tosilate for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE
Measured: Within 3 days of receiving gastroscopy and colonoscopy
Secondary outcomes (3)
Serious adverse events
Refer to SAE definition standards
Measured: Within 3 days of receiving gastroscopy and colonoscopy
Adverse drug reactions
By evaluating the association of adverse events with drugs
Measured: Within 3 days of receiving gastroscopy and colonoscopy
Injection pain questionnaire
By observing and asking
Measured: Within 3 days of receiving gastroscopy and colonoscopy
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 start30 Jan 2022
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroscopic and Colonoscopic SedationStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254366
- Sponsor's protocol ID
- ARMS
- Status last verified
- Sep 2026
- First submitted
- 28 Jan 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Domestic, Prospective, Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
- ClinicalTrials.gov ID
- NCT05254366
- Acronym / sponsor ID
- ARMS
- Conditions
- Gastroscopic and Colonoscopic Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,022 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- 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.
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Remimazolam Tosilate for InjectionPainless gastroscopic sedation cohort |
| Cohort 2 | – | Drug: Remimazolam Tosilate for InjectionPainless colonoscopy sedation cohort |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving remazolam toluenesulfonate for painless gastroscopy and colonoscopy
Key inclusion criteria (2 listed)
- Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
- Patients need to sign informed consent
Key exclusion criteria (2 listed)
- Patients who are participating in or planning to participate in any interventional clinical trial
- The investigator considers that there are any other reasons for the patient's ineligibility for the study
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 Tosilate for InjectionRemimazolam Tosilate for Injection | Drug | Cohort 1, Cohort 2 |
Primary outcome
Adverse events
Time frame: Within 3 days of receiving gastroscopy and colonoscopy
Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE
3 secondary outcomes
Serious adverse events
Time frame: Within 3 days of receiving gastroscopy and colonoscopy
Adverse drug reactions
Time frame: Within 3 days of receiving gastroscopy and colonoscopy
Injection pain questionnaire
Time frame: Within 3 days of receiving gastroscopy and colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroscopic and Colonoscopic Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 19 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Within 3 days of receiving gastroscopy and colonoscopy). 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 21 Sep 2026.