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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Active Comparator | The patient with midazolam |
|
| Remimazolam | Experimental | The patient with remimazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | The patient with remimazolam |
| |
| Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | begin when the drug is give to when the endoscopy is withdrawn |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of sedation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taejun Kim | Samsung Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41965699 | Derived | 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. | |
| 41284133 | Derived | Park 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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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
The patient with midazolam |
|
| D006571 | Heterocyclic Compounds |