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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
the time from the end of the procedure to full alertness in both groups.
The Time for patient to recover Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores to 5 after end of bronchoscopy MOAA/S scores: 5 = Responds readily to name spoken in normal tone \[alert\], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze. MOAA/S scores were assessed by the investigators.
Time frame: up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)
the time taken to reach peak sedation
The degree of sedation was measured using the Modified Observer's Alertness/Sedation scale (MOAA/S), and bronchoscopy was performed under adequate sedation (MOAA/S≤3)
Time frame: up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)
physician satisfaction after the procedure
Physician satisfaction with sedation was expressed as a score ranging from -5 to 5 after completion of the procedure (-5 = not satisfied at all, 5 = maximally satisfied).
Time frame: up to 1day
patient satisfaction after the procedure
Patient satisfaction was measured using a visual analog scale (0 = intolerable, 10 = free from inconvenience).
Time frame: up to 1day
difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.
adverse effects that occur during and after the procedure
Time frame: up to 30days (the first dose to the end of the procedure was defined as the time from the first sedative drug administration to mouth exit.)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.