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

NCT ID: NCT05254366

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2022 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-30

Study Completion Date

2023-02-08

Brief Summary

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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

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Conditions

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Gastroscopic and Colonoscopic Sedation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Painless gastroscopic sedation cohort

Remimazolam Tosilate for Injection

Intervention Type DRUG

Remimazolam Tosilate for Injection

Cohort 2

Painless colonoscopy sedation cohort

Remimazolam Tosilate for Injection

Intervention Type DRUG

Remimazolam Tosilate for Injection

Interventions

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Remimazolam Tosilate for Injection

Remimazolam Tosilate for Injection

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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ARMS

Identifier Type: -

Identifier Source: org_study_id

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