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

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

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 Overview

• Status: Completed
• Conditions: Gastroscopic and Colonoscopic Sedation
• Intervention / Treatment: Drug: Remimazolam Tosilate for Injection

• Study Type: Observational
• Enrollment (Actual): 2022

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430021
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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 painless gastroscopy and colonoscopy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Painless gastroscopic sedation cohort	Drug: Remimazolam Tosilate for Injection; Remimazolam Tosilate for Injection
Cohort 2; Painless colonoscopy 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 gastroscopy and colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Refer to SAE definition standards	Within 3 days of receiving gastroscopy and colonoscopy
Adverse drug reactions	By evaluating the association of adverse events with drugs	Within 3 days of receiving gastroscopy and colonoscopy
Injection pain questionnaire	By observing and asking	Within 3 days of receiving gastroscopy and colonoscopy

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2022
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 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