Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the time from the end of the procedure to full alertness in both groups.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥18 years who required diagnostic or therapeutic bronchoscopy and agreed to participate
排除标准
- •pregnancy, 2) moderate-to-severe hepatic impairment and lactose intolerance 3) mechanical ventilation 4) history of tracheostomy 5) poor patient cooperation
研究组 & 干预措施
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.
干预措施: Midazolam (Drug)
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.
干预措施: Byfavo (Drug)
结局指标
主要结局
the time from the end of the procedure to full alertness in both groups.
时间窗: 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
时间窗: 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)
次要结局
- 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.))
研究者
Bumhee Yang, MD
Associator professor M.D. PhD.
Chungbuk National University Hospital