Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Minia University

Status and phase: Unknown; Phase 1

Conditions: Diffuse Traumatic Cerebral Edema

Treatments: Drug: Progesteron

Study type: Interventional

Funder types: Other

Identifiers

NCT04414020

623-4/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All elective brain tumors elligible for craniotomy

Exclusion criteria

• Refusal to participare
• Emergency craniotomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Control

No Intervention group

Description:

Control group receiving conventional treatment without progesterone

progesterone group

Active Comparator group

Description:

1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface

Treatment:

Drug: Progesteron