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
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