HealthyPhase 3NCT05836545
Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
A Phase 3 study testing Remimazolam and Midazolam in people with Healthy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are: Superiority of total procedure time in remimazolam compared to midazolam The success of sedation time This is the single blind study.… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Remimazolam and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2023to 6 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who agreed for this clinical trials
- Patients who want diagnostic endoscopy under sedation
- The total procedure time which is predicted within 15 minutes
- ASA >=2
- BMI more than 18.5kg/m2, less than 30kg/m2
Who cannot join
- Patients who have stomach illness
- Patients with respiratory disease
- Mallampati Score>=3
- Systolic BP >160mmHg or <90mmHg
- Refractory Hypertension
- Uncontrolled glaucoma
Show all 12Show fewer
- Severe liver failure or chronic kidney disease
- Patients with drug abuse or alcohol abuse within 1 year
- Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam)
- Obstructive sleep dyspnea patients
- Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Pregnant, breast feeding patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are:
- Superiority of total procedure time in remimazolam compared to midazolam
- The success of sedation time
This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
The patient with remimazolam
MidazolamDrug
The patient with midazolam
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | The patient with midazolam Receives: Drug: Midazolam |
| Remimazolam | Experimental | The patient with remimazolam Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total procedure time
Measured: begin when the drug is give to when the endoscopy is withdrawn
Secondary outcomes (1)
The success rate of sedation
Measured: Completion of the whole endoscopy procedures, No requirement for an alternative and/or rescue sedative, Administered up to a maximum of five supplemental doses within 15 mnutes after the initial dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start5 Apr 2023
- Primary completion6 Jan 2024
- Study completion6 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taejun Kim, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836545
- Sponsor's protocol ID
- 2022-08-2391
- Status last verified
- Nov 2025
- First submitted
- 19 Apr 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahn DW, Lee JK, Lee KH, Kim T, Kang SH, Park Y, Kim SB, Kim SJ. Remimazolam versus midazolam for sedation in diagnostic upper gastrointestinal endoscopy: study protocol for a randomized controlled trial. Trials. 2026 Apr 11;27(1):376. doi: 10.1186/s13063-026-09712-5.
PubMed 41965699Park Y, Lee JK, Lee KH, Kim T, Kang SH, Ahn DW, Kim SB, Kim SJ. Remimazolam Enables Faster Sedation Induction and Recovery Compared With Midazolam in Diagnostic Upper Gastrointestinal Endoscopy: A Multicenter Randomized Controlled Trial. United European Gastroenterol J. 2026 Feb;14(1):e70147. doi: 10.1002/ueg2.70147. Epub 2025 Nov 24.
PubMed 41284133
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT05836545
- Acronym / sponsor ID
- 2022-08-2391
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- 6 Jan 2024 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are:
- Superiority of total procedure time in remimazolam compared to midazolam
- The success of sedation time
This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: MidazolamThe patient with midazolam |
| Remimazolam | Experimental | Drug: RemimazolamThe patient with remimazolam |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who agreed for this clinical trials
- Patients who want diagnostic endoscopy under sedation
- The total procedure time which is predicted within 15 minutes
- ASA >=2
- BMI more than 18.5kg/m2, less than 30kg/m2
Key exclusion criteria (12 listed)
- Patients who have stomach illness
- Patients with respiratory disease
- Mallampati Score>=3
- Systolic BP >160mmHg or <90mmHg
- Refractory Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamThe patient with remimazolam | Drug | Remimazolam |
| MidazolamThe patient with midazolam | Drug | Midazolam |
Primary outcome
Total procedure time
Time frame: begin when the drug is give to when the endoscopy is withdrawn
1 secondary outcome
The success rate of sedation
Time frame: Completion of the whole endoscopy procedures, No requirement for an alternative and/or rescue sedative, Administered up to a maximum of five supplemental doses within 15 mnutes after the initial dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 41965699Ahn DW, Lee JK, Lee KH, Kim T, Kang SH, Park Y, Kim SB, Kim SJ. Remimazolam versus midazolam for sedation in diagnostic upper gastrointestinal endoscopy: study protocol for a randomized controlled trial. Trials. 2026 Apr 11;27(1):376. doi: 10.1186/s13063-026-09712-5.
- Derived from this study: PubMed 41284133Park Y, Lee JK, Lee KH, Kim T, Kang SH, Ahn DW, Kim SB, Kim SJ. Remimazolam Enables Faster Sedation Induction and Recovery Compared With Midazolam in Diagnostic Upper Gastrointestinal Endoscopy: A Multicenter Randomized Controlled Trial. United European Gastroenterol J. 2026 Feb;14(1):e70147. doi: 10.1002/ueg2.70147. Epub 2025 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taejun Kim study director
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remimazolam and Midazolam in people with Healthy, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total procedure time (time frame: begin when the drug is give to when the endoscopy is withdrawn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05836545, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.