Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Midazolam
- Conditions
- Bronchoscopy
- Sponsor
- Chungbuk National University Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- the time from the end of the procedure to full alertness in both groups.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Bumhee Yang, MD
Associator professor M.D. PhD.
Chungbuk National University Hospital
Eligibility Criteria
Inclusion Criteria
- •aged ≥18 years who required diagnostic or therapeutic bronchoscopy and agreed to participate
Exclusion Criteria
- •pregnancy, 2) moderate-to-severe hepatic impairment and lactose intolerance 3) mechanical ventilation 4) history of tracheostomy 5) poor patient cooperation
Arms & Interventions
Midazolam
Patients aged \<60 years or weighing \>50 kg were randomly assigned to receive 3 mg intravenous midazolam. In contrast, those aged ≥60 years or with a body weight of \<50 kg were assigned 2 mg intravenous. If adequate sedation was not achieved after the initial sedative administration, additional midazolam (0.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician.
Intervention: Midazolam
Remimazolam
Patients aged \<60 years or weighing \>50 kg were randomly assigned to receive 5 mg remimazolam. In contrast, those aged ≥60 years or with a body weight of \<50 kg were assigned intravenous 3 mg remimazolam. If adequate sedation was not achieved after the initial sedative administration, additional remimazolam (2.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician.
Intervention: Byfavo
Outcomes
Primary Outcomes
the time from the end of the procedure to full alertness in both groups.
Time Frame: up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)
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.
the time taken to reach peak sedation
Time Frame: up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)
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)
Secondary Outcomes
- patient satisfaction after the procedure(up to 1day)
- physician satisfaction after the procedure(up to 1day)
- difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.(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.))