Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
- Registration Number
- NCT04414020
- Lead Sponsor
- Minia University
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
- All elective brain tumors elligible for craniotomy
- Refusal to participare
- Emergency craniotomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description progesterone group Progesteron 1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface
- Primary Outcome Measures
Name Time Method Number of Participants With craniotomy-Related Adverse Events 3 months Degree of microscopic cellular injury and brain odema in brain biopsy
- Secondary Outcome Measures
Name Time Method Number of Participants with neuronal deficit 2 months Sensory, motor or autonomic dysfunction
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Minya, Abohelal, Egypt