DRKS00034040招募中2 期
Trial of Awake Burr Hole Craniotomy in Patients with Chronic Subdural Hematoma (ABC-SDH trial I): a safety and feasibility randomized controlled trial - ABC-SDH I
Charité - Universitätsmedizin Berlin, Klinik für Neurochirurgie0 个研究点目标入组 50 人开始时间: 2024年4月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Adult patients (age = 18 years)
- •- Symptomatic and asymptomatic cSDH confirmed by imaging (MRI/CT) that require surgical treatment
- •- Informed consent of the patient. Only patients capable of giving informed consent will be included.
排除标准
- •- No consent for participation
- •- Bilateral cSDH, both of which require surgical treatment
- •- Preoperative delirium
- •- Patients with conditions for which surgery under local or general anaesthesia is contraindicated
- •o Known allergy to lidocaine or bupivacaine
- •o Known allergy or contraindication to epinephrine
- •o Patients with a history of psychiatric disorders that could make awake surgery difficult and jeopardise the patient's safety during surgery (panic disorder/episodic paroxysmal anxiety, claustrophobia)
- •- Previous participation in this study
- •- Time interval from admission to surgery > 24 hours
- •- CSDH in the presence of a CSF shunt
研究者
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