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Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04414020
Enrollment
26
Registered
2020-06-04
Start date
2020-06-01
Completion date
2020-09-30
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Traumatic Cerebral Edema

Keywords

Progesterone, brain tumor, Neuronal biopsy

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.

Interventions

DRUGProgesteron

intramusculer progesterone

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* All elective brain tumors elligible for craniotomy

Exclusion criteria

* Refusal to participare * Emergency craniotomy

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With craniotomy-Related Adverse Events3 monthsDegree of microscopic cellular injury and brain odema in brain biopsy

Secondary

MeasureTime frameDescription
Number of Participants with neuronal deficit2 monthsSensory, motor or autonomic dysfunction

Countries

Egypt

Contacts

Primary ContactMina Raouf, MD
drmina2015@gmail.com01015752424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026