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NCT05836545
Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
Phase 3 trial testing Remimazolam in Healthy in 132 participants. Completed in 6 January 2024.
6 January 2024
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 132 |
| Start date | 5 April 2023 |
| Primary completion | 6 January 2024 |
| Estimated completion | 6 January 2024 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Remimazolam — full drug profile →
- Midazolam (midazolam) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Samsung Medical Center
Who can join
Adults 18 to 60, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Remimazolam Enables Faster Sedation Induction and Recovery Compared With Midazolam in Diagnostic Upper Gastrointestinal Endoscopy: A Multicenter Randomized Controlled Trial.
Park Y, Lee JK, Lee KH, Kim T, et al · · 2026 · cited 2× · PMID 41284133 · DOI 10.1002/ueg2.70147 -
Remimazolam versus midazolam for sedation in diagnostic upper gastrointestinal endoscopy: study protocol for a randomized controlled trial.
Ahn DW, Lee JK, Lee KH, Kim T, et al · · 2026 · PMID 41965699 · DOI 10.1186/s13063-026-09712-5
Verify or expand the search:
- PubMed search for NCT05836545
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Samsung Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05836545 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samsung Medical Center
- Last refreshed: 18 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05836545.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing