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Thousands observed: is this sedative safe for routine scopes?

NCT ID NCT05254366

Knowledge-focused Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This completed study observed over 2,000 patients in China who received remimazolam, a short-acting sedative, during painless gastroscopy or colonoscopy. The goal was to collect real-world safety information, including side effects and serious adverse events. No new treatment was given; researchers simply watched and recorded what happened.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Remimazolam (a short-acting sedative)
What this could lead to
If successful, this study could confirm that remimazolam is safe for routine use during gastroscopy and colonoscopy in Chinese patients.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove effectiveness. Results may not apply to other populations or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,022 people

The number who actually took part.

Started

Jan 2022

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients receiving remazolam toluenesulfonate for painless gastroscopy and colonoscopy

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation 2. Patients need to sign informed consent Exclusion Criteria: 1. Patients who are participating in or planning to participate in any interventional clinical trial 2. The investigator considers that there are any other reasons for the patient's ineligibility for the study

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroscopic and colonoscopic sedation

Contacts and locations

Locations

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong, 250012, China

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256600, China

  • Changshu No.2 People's Hospital (Affiliated Changshu Hospital of Nantong University)

    Changshu, Jiangsu, 215500, China

  • Dazhou Central Hospital

    Dazhou, Sichaun, 63500, China

  • First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041, China

  • Hunan Provincial People's Hospital and The First Affiliated Hospital of Hunan Normal University

    Changsha, Hunan, 410005, China

  • Leshan People's Hospital

    Leshan, Sichuan, 614000, China

  • Linyi People's Hospital

    Linyi, Shandong, 276000, China

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200011, China

  • Shengli Oilfield Central Hospital

    Dongying, Guangxi, 257034, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020, China

  • Suqian People's Hospital of Nanjing Drum Tower Hospital Group

    Suqian, Jiangsu, 223800, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The People's Hospital of Chizhou

    Chizhou, Anhui, 247000, China

  • Tianjin Nankai Hospital, Tianjin Medical University

    Tianjin, Tianjin Municipality, 300100, China

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

    Wuhan, Hubei, 430022, China

  • Wuhan Central Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430014, China

  • Zhangjiagang First People's Hospital

    Suzhou, Jiangsu, 215600, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071, China