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

Jiangsu HengRui Medicine Co., Ltd.1,285 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,285

Conditions

General Anesthesia and Bronchoscopy Sedation

Interventions

Remimazolam Tosilate for InjectionDRUG

Remimazolam Tosilate for Injection

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Xiangya Hospital of Central South University

Changsha, Hunan, China

Outcomes

Primary Outcomes

Adverse events

Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE

Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

Secondary Outcomes

Serious adverse events

Refer to SAE definition standards

Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

Adverse drug reactions

By evaluating the association of adverse events with drugs

Time frame: 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

Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

Data from ClinicalTrials.gov

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