Gastroscopic and Colonoscopic SedationNCT05254366

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

An observational study of Gastroscopic and Colonoscopic Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Gastroscopic and Colonoscopic Sedation
What is being tested?: Remimazolam Tosilate for Injection
Type of treatment: Injection or infusion
How many people: 2,022 participants
Where: 19 sitesChina
Study dates: 30 Jan 2022to 8 Feb 2023
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: All patients receiving remazolam toluenesulfonate for painless gastroscopy and colonoscopy

Who may be able to join

Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
Patients need to sign informed consent

Who cannot join

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

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

China19 sites

Binzhou Medical University Hospital
Binzhou, Shandong, 256600
Hunan Provincial People's Hospital and The First Affiliated Hospital of Hunan Normal University
Changsha, Hunan, 410005
Changshu No.2 People's Hospital (Affiliated Changshu Hospital of Nantong University)
Changshu, Jiangsu, 215500
The People's Hospital of Chizhou
Chizhou, Anhui, 247000
Dazhou Central Hospital
Dazhou, Sichaun, 63500
Shengli Oilfield Central Hospital
Dongying, Guangxi, 257034
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250012
Leshan People's Hospital
Leshan, Sichuan, 614000
Linyi People's Hospital
Linyi, Shandong, 276000
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Suqian People's Hospital of Nanjing Drum Tower Hospital Group
Suqian, Jiangsu, 223800
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600
Tianjin Nankai Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, 300100
Wuhan Central Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430014
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071

Other trials in China

About this study

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

Conditions: Gastroscopic and Colonoscopic Sedation
Being tested: Remimazolam Tosilate for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remimazolam Tosilate for InjectionDrug
Remimazolam Tosilate for Injection

Study groups in NCT05254366
Study group	Role	What they receive
Cohort 1		Painless gastroscopic sedation cohort Receives: Drug: Remimazolam Tosilate for Injection
Cohort 2		Painless colonoscopy sedation cohort Receives: Drug: Remimazolam Tosilate for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE
Measured: Within 3 days of receiving gastroscopy and colonoscopy

Secondary outcomes (3)

Serious adverse events
Refer to SAE definition standards
Measured: Within 3 days of receiving gastroscopy and colonoscopy
Adverse drug reactions
By evaluating the association of adverse events with drugs
Measured: Within 3 days of receiving gastroscopy and colonoscopy
Injection pain questionnaire
By observing and asking
Measured: Within 3 days of receiving gastroscopy and colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 20228 Feb 2023

First posted24 Feb 2022
Study start30 Jan 2022
Primary completion8 Feb 2023
Study completion8 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastroscopic and Colonoscopic SedationStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,022 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05254366
Sponsor's protocol ID: ARMS
Status last verified: Sep 2026
First submitted: 28 Jan 2022
Last updated: 21 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided