2025-523543-36-00招募中4 期
Study on the influence of FLUMAzenil regarding the incidence of pediatric emergence delirium (ED) in children undergoing ENT surgery – FLUMA Study
Rheinische Friedrich-Wilhelms-Universitaet Bonn1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2026年1月23日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The occurrence of postoperative delirium (pädED) until discharge from the recovery room. A score of ≥ 10 points is indicative of delirium.
研究概览
简要总结
The FLUMA Study will examine the occurrence of pediatric emergence delirium in children following ENT surgery after antagonisation of the sedative effect of Midazolam (Dormicum®) by Flumazenil®.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children aged 3-7
- •ASA status I and II
- •ENT anesthesia, regardless of the procedure
- •Consent of the legal guardian
- •Sufficient language skills in German
排除标准
- •ASA status III or IV
- •Lack of consent from the legal guardian
- •Contraindications for the use of benzodiazepines or flumazenil
结局指标
主要结局
The occurrence of postoperative delirium (pädED) until discharge from the recovery room. A score of ≥ 10 points is indicative of delirium.
The occurrence of postoperative delirium (pädED) until discharge from the recovery room. A score of ≥ 10 points is indicative of delirium.
次要结局
未报告次要终点
研究者
Univ.-Prof. Dr. med. Dr. habil Ehrenfried Schindler
Scientific
Rheinische Friedrich-Wilhelms-Universitaet Bonn
研究点 (1)
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