A Non-interventional Study of Remazolam Methyl Benzene Su... | NCT05254366

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

NCT05254366

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Completed

Last Update Posted

Jan 5, 2026Actual

Enrollment

2,022Actual

Phase

Not provided

Conditions

Gastroscopic and Colonoscopic Sedation

Interventions

Remimazolam Tosilate for Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2022Actual

Primary Completion Date

Feb 8, 2023Actual

Completion Date

Feb 8, 2023Actual

First Submitted Date

Jan 28, 2022

First Submission Date that Met QC Criteria

Feb 23, 2022

First Posted Date

Feb 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2025

Last Update Posted Date

Jan 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,022Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		Painless gastroscopic sedation cohort	Drug: Remimazolam Tosilate for Injection
Cohort 2		Painless colonoscopy sedation cohort	Drug: Remimazolam Tosilate for Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remimazolam Tosilate for Injection	Drug	Remimazolam Tosilate for Injection	Cohort 1 Cohort 2

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
Patients need to sign informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients receiving remazolam toluenesulfonate for painless gastroscopy and colonoscopy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei	430021	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007267	Injections

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided