NCT05549791

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

August 24, 2022

Last Update Submit

December 30, 2025

Conditions

General Anesthesia and Bronchoscopy Sedation

Outcome Measures

Primary Outcomes (1)

  • Adverse events

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

    Within 3 days of receiving General anesthesia and bronchoscopy sedation

Secondary Outcomes (3)

  • Serious adverse events

    Within 3 days of receiving General anesthesia and bronchoscopy sedation

  • Adverse drug reactions

    Within 3 days of receiving General anesthesia and bronchoscopy sedation

  • Injection pain

    Within 3 days of receiving General anesthesia and bronchoscopy sedation

Study Arms (2)

General anesthesia cohort

Drug: Remimazolam Tosilate for Injection

Bronchoscopy sedation cohort

Drug: Remimazolam Tosilate for Injection

Interventions

Remimazolam Tosilate for InjectionDRUG

Remimazolam Tosilate for Injection

Bronchoscopy sedation cohortGeneral anesthesia cohort

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving remazolam toluenesulfonate for general anesthesia or bronchoscopy sedation

You may qualify if:

  • Patients using rebinim ® during general anesthesia and fiberoptic sedation
  • Patients need to sign informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2022

First Posted

September 22, 2022

Study Start

August 18, 2022

Primary Completion

June 21, 2024

Study Completion

June 21, 2024

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

CN(1)