NCT05254366

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,022

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 28, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2023

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

January 28, 2022

Last Update Submit

December 30, 2025

Conditions

Gastroscopic and Colonoscopic 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 gastroscopy and colonoscopy

Secondary Outcomes (3)

  • Serious adverse events

    Within 3 days of receiving gastroscopy and colonoscopy

  • Adverse drug reactions

    Within 3 days of receiving gastroscopy and colonoscopy

  • Injection pain questionnaire

    Within 3 days of receiving gastroscopy and colonoscopy

Study Arms (2)

Cohort 1

Painless gastroscopic sedation cohort

Drug: Remimazolam Tosilate for Injection

Cohort 2

Painless colonoscopy sedation cohort

Drug: Remimazolam Tosilate for Injection

Interventions

Remimazolam Tosilate for InjectionDRUG

Remimazolam Tosilate for Injection

Cohort 1Cohort 2

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 painless gastroscopy and colonoscopy

You may qualify if:

  • Use rebenin ® for painless gastroscopic sedation and painless colonoscopic 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)

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

Wuhan, Hubei, 430021, 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

January 28, 2022

First Posted

February 24, 2022

Study Start

January 30, 2022

Primary Completion

February 8, 2023

Study Completion

February 8, 2023

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

CN(1)