A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy

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

Study Overview

• Status: Completed
• Conditions: General Anesthesia and Bronchoscopy Sedation
• Intervention / Treatment: Drug: Remimazolam Tosilate for Injection

• Study Type: Observational
• Enrollment (Actual): 1285

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patients receiving remazolam toluenesulfonate for general anesthesia or bronchoscopy sedation

Description

Inclusion Criteria:

1. Patients using rebinim ® during general anesthesia and fiberoptic sedation
2. Patients need to sign informed consent

Exclusion Criteria:

1. Patients who are participating in or planning to participate in any interventional clinical trial
2. The investigator considers that there are any other reasons for the patient's ineligibility for the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General anesthesia cohort	Drug: Remimazolam Tosilate for Injection; Remimazolam Tosilate for Injection
Bronchoscopy sedation cohort	Drug: Remimazolam Tosilate for Injection; Remimazolam Tosilate for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE	Within 3 days of receiving General anesthesia and bronchoscopy sedation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Refer to SAE definition standards	Within 3 days of receiving General anesthesia and bronchoscopy sedation
Adverse drug reactions	By evaluating the association of adverse events with drugs	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	Within 3 days of receiving General anesthesia and bronchoscopy sedation

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: ARMS-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No