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OpenTrials
Completed

NCT Number: NCT05549791

A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy

This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 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

General Anesthesia and Bronchoscopy Sedation

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients using rebinim ® during general anesthesia and fiberoptic 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 General anesthesia and bronchoscopy sedation

    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 General anesthesia and bronchoscopy sedation

    Refer to SAE definition standards

  2. Adverse drug reactions

    Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

    By evaluating the association of adverse events with drugs

  3. Injection pain

    Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

    Refer to the NCI-CTCAE <5.0> grading criteria for drug injection site reactions

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Domestic, Prospective, Non-interventional Study of Remimazolam Tosilate for Injection in the Real-world for General Anesthesia and Fiberoptic Bronchoscopy Sedation

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 22, 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.