Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants With craniotomy-Related Adverse Events
研究概览
简要总结
Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty
详细描述
Progesterone is a natural neurosteroid that we are trying to use to impede both direct neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain tumor.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All elective brain tumors elligible for craniotomy
排除标准
- •Refusal to participare
- •Emergency craniotomy
研究组 & 干预措施
progesterone group
1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface
干预措施: Progesteron (Drug)
结局指标
主要结局
Number of Participants With craniotomy-Related Adverse Events
时间窗: 3 months
Degree of microscopic cellular injury and brain odema in brain biopsy
次要结局
- Number of Participants with neuronal deficit(2 months)
研究者
Mina Maher
Principle investigator
Ministry of Health and Population, Egypt