Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

M

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

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

Trial contacts and locations

2

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Central trial contact

Mina Raouf, MD

Data sourced from clinicaltrials.gov

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