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

• Conditions: General Anesthesia and Bronchoscopy Sedation
• Interventions: Drug: Remimazolam Tosilate for Injection

• Registration Number: NCT05549791
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-24
• Study Start: 2022-09
• Study First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General anesthesia cohort	Remimazolam Tosilate for Injection	-
Bronchoscopy sedation cohort	Remimazolam Tosilate for Injection	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serious adverse events	Within 3 days of receiving General anesthesia and bronchoscopy sedation	Refer to SAE definition standards
Adverse drug reactions	Within 3 days of receiving General anesthesia and bronchoscopy sedation	By evaluating the association of adverse events with drugs
Injection pain	Within 3 days of receiving General anesthesia and bronchoscopy sedation	Refer to the NCI-CTCAE \<5.0\> grading criteria for drug injection site reactions