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NCT05994547
Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial
Phase 4 trial testing Byfavo in Bronchoscopy in 100 participants. Completed in 15 June 2023.
15 June 2023
Quick facts
| Lead sponsor | Chungbuk National University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 14 April 2022 |
| Primary completion | 15 June 2023 |
| Estimated completion | 15 June 2023 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
Conditions studied
- Bronchoscopy — all drugs for Bronchoscopy →
- Remimazolam — all drugs for Remimazolam →
Sponsor
Chungbuk National University Hospital
Who can join
18 and older, any sex, with Bronchoscopy or Remimazolam. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objectives: Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. This study compared the safety and efficacy of remimazolam with that of midazolam for bronchoscopy. Design: A single-center, prospective randomized parallel-group study Setting: Chungbuk National University Hospital, April 2022-June 2023. Participants: One hundred patients were enrolled; 51 were randomly assigned to the midazolam group and 49 to the remimazolam group. Respiratory nurse specialists performed the randomization. Interventions: Oral and laryngeal anesthesia was induced using a 4% lidocaine nebulizer prior to sedation. The vocal cords and lower airway tract were anesthetized. Patients aged \<60 years or weighing \>50 kg received 3 mg intravenous midazolam or 5 mg remimazolam. Patients aged ≥60 years or weighing \<50 kg received 2 mg intravenous midazolam or 3 mg remimazolam. Bronchoscopy was performed under adequate sedation (MOAA/S≤3) Main outcome measures: The primary outcome was the time from the end of the procedure to full alertness. Secondary outcomes were procedural time parameters, satisfaction profiles, and adverse effects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety and efficacy of remimazolam compared with midazolam during bronchoscopy: a single-center, randomized controlled study.
Kim SH, Cho JY, Kim M, Chung JM, et al · · 2023 · cited 27× · PMID 37993525 · DOI 10.1038/s41598-023-47271-w
Verify or expand the search:
- PubMed search for NCT05994547
- Europe PMC full search
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Related trials
Other trials of Byfavo
Trials testing the same drug.
- NCT06275594 — Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration · Phase 2 · unknown
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Currently open trials in the same condition.
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Other Chungbuk National University Hospital trials
Trials by the same sponsor.
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- NCT04552574 — Randomized Clinical Trial of HMR(Home Meal Replacement)-Type Omega-3-balanced-diet · NA · unknown
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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 NCT05994547 (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 Chungbuk National University Hospital
- Last refreshed: 16 August 2023
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/NCT05994547.
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