Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 204
- 主要终点
- Incidence of Emergence Agitation
研究概览
简要总结
Participants will be randomly assigned to receive general anesthesia with either remimazolaml-based total intravenous anesthesia reversed with flumazenil or propofol-based total intravenous anesthesia. The primary outcome is the incidence of emergence agitation evaluated at the time of awakening after surgery. Additional outcomes include time to extubation, hemodynamic stability, airway complications such as coughing or laryngospasm, and postoperative recovery profiles including pain, nausea, vomiting, and sedation in the post-anesthesia care unit. This study aims to determine whether remimazolam with flumazenil provides smoother emergence compared with propofol in patients undergoing nasal surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Remimazolam
Participants receive general anesthesia induced and maintained with remimazolam-based total intravenous anesthesia. At the end of surgery, flumazenil (0.2-1.0 mg) is administered to reverse the sedative effect.
干预措施: Remimazolam with Flumazenil (Drug)
Propofol
Participants receive general anesthesia induced and maintained with propofol.
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence of Emergence Agitation
时间窗: From discontinuation of anesthesia to exit in the operating room
次要结局
- Time to Tracheal Extubation(From anesthesia discontinuation to extubation in the operating room)
- Intraoperative Hemodynamic Stability(During anesthesia)
- Incidence of Airway Complications During Emergence(during anesthesia)