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NCT05994547

Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial

Completed Phase 4 Last updated 16 August 2023
What this trial tests

Phase 4 trial testing Byfavo in Bronchoscopy in 100 participants. Completed in 15 June 2023.

Timeline
14 April 2022
Primary endpoint
15 June 2023
15 June 2023

Quick facts

Lead sponsorChungbuk National University Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment100
Start date14 April 2022
Primary completion15 June 2023
Estimated completion15 June 2023
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other trials of Byfavo

Trials testing the same drug.

Other recruiting trials for Bronchoscopy

Currently open trials in the same condition.

Other Chungbuk National University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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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