A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice

Jiangsu HengRui Medicine Co., Ltd.2,022 enrolled

Overview

This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained

Study Type

OBSERVATIONAL

Enrollment

2,022

Conditions

Gastroscopic and Colonoscopic Sedation

Interventions

Remimazolam Tosilate for InjectionDRUG

Remimazolam Tosilate for Injection

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Use rebenin ® for painless gastroscopic sedation and painless colonoscopic 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)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 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 gastroscopy and colonoscopy

Secondary Outcomes

Serious adverse events

Refer to SAE definition standards

Time frame: Within 3 days of receiving gastroscopy and colonoscopy

Adverse drug reactions

By evaluating the association of adverse events with drugs

Time frame: Within 3 days of receiving gastroscopy and colonoscopy

Injection pain questionnaire

By observing and asking

Time frame: Within 3 days of receiving gastroscopy and colonoscopy

Data from ClinicalTrials.gov

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