General Anesthesia and Bronchoscopy SedationNCT05549791
A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy
An observational study of General Anesthesia and Bronchoscopy Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 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
- General Anesthesia and Bronchoscopy Sedation
- What is being tested?
- Remimazolam Tosilate for Injection
- Type of treatment
- Injection or infusion
- How many people
- 1,285 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2022to 21 Jun 2024
- 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 general anesthesia or bronchoscopy sedation
Who may be able to join
- Patients using rebinim ® during general anesthesia and fiberoptic 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
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
About this study
Official title: A Domestic, Prospective, Non-interventional Study of Remimazolam Tosilate for Injection in the Real-world for General Anesthesia and Fiberoptic Bronchoscopy Sedation
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained
- 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 |
|---|---|---|
| General anesthesia cohort | Not described Receives: Drug: Remimazolam Tosilate for Injection | |
| Bronchoscopy sedation cohort | Not described 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 General anesthesia and bronchoscopy sedation
Secondary outcomes (3)
Serious adverse events
Refer to SAE definition standards
Measured: Within 3 days of receiving General anesthesia and bronchoscopy sedation
Adverse drug reactions
By evaluating the association of adverse events with drugs
Measured: Within 3 days of receiving General anesthesia and bronchoscopy sedation
Injection pain
Refer to the NCI-CTCAE <5.0> grading criteria for drug injection site reactions
Measured: Within 3 days of receiving General anesthesia and bronchoscopy sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start18 Aug 2022
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia and Bronchoscopy 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
- 1,285 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
- NCT05549791
- Sponsor's protocol ID
- ARMS-
- Status last verified
- Dec 2025
- First submitted
- 24 Aug 2022
- Last updated
- 5 Jan 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Domestic, Prospective, Non-interventional Study of Remimazolam Tosilate for Injection in the Real-world for General Anesthesia and Fiberoptic Bronchoscopy Sedation
- ClinicalTrials.gov ID
- NCT05549791
- Acronym / sponsor ID
- ARMS-
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,285 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 22 Sep 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 1000 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 |
|---|---|---|
| General anesthesia cohort | – | Drug: Remimazolam Tosilate for Injection |
| Bronchoscopy sedation cohort | – | Drug: Remimazolam Tosilate for Injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving remazolam toluenesulfonate for general anesthesia or bronchoscopy sedation
Key inclusion criteria (2 listed)
- Patients using rebinim ® during general anesthesia and fiberoptic 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 | Bronchoscopy sedation cohort, General anesthesia cohort |
Primary outcome
Adverse events
Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation
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 General anesthesia and bronchoscopy sedation
Adverse drug reactions
Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation
Injection pain
Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation
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 5 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Bronchoscopy Sedation, run by Jiangsu HengRui Medicine Co., Ltd. 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 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 5 Jan 2026. 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. 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 General anesthesia and bronchoscopy sedation). 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 5 Jan 2026.