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OpenTrials
Completed

NCT Number: NCT05254366

A 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

Completed

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Key information

Conditions

Gastroscopic and Colonoscopic Sedation

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430021, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam Tosilate for injection

Drug

Remimazolam Tosilate for Injection

Primary outcomes

  1. Adverse events

    Time frame: Within 3 days of receiving gastroscopy and colonoscopy

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

Secondary outcomes

  1. Serious adverse events

    Time frame: Within 3 days of receiving gastroscopy and colonoscopy

    Refer to SAE definition standards

  2. Adverse drug reactions

    Time frame: Within 3 days of receiving gastroscopy and colonoscopy

    By evaluating the association of adverse events with drugs

  3. Injection pain questionnaire

    Time frame: Within 3 days of receiving gastroscopy and colonoscopy

    By observing and asking

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2022
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.