Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Richmond agitation sedation scale
研究概览
简要总结
The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries (septoplasty, rhinoseptoplasty or functional endoscopic sinus surgery).
Patients aged 18-65, ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline solution.
The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be the postoperative pain level, the length of stay in the recovery room, the presence of unwanted events in the recovery room, and the presence of postoperative mood changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for rhinoplasty, rhinoseptoplasty or FESS
- •ASA I or II
排除标准
- •pregnancy
- •patients treated with psychiatric medication (in the time of operation or 6 months prior to operation)
研究组 & 干预措施
1
干预措施: Remimazolam 20 MG Injection [Byfavo] (Drug)
2
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
Richmond agitation sedation scale
时间窗: Immediately after extubation and every five minutes after that for half hour
次要结局
未报告次要终点
研究者
Grgur Prižmić
MD
University Hospital of Split