Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Diffuse Traumatic Cerebral Edema Clinical Trial

Official title:

Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414020
• Other study ID #: 623-4/2020
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2020
• Source: Minia University
• Contact: Mina Raouf, MD
• Phone: 01015752424
• Email: drmina2015[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: September 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• All elective brain tumors elligible for craniotomy

Exclusion Criteria:

• Refusal to participare

• Emergency craniotomy

Related Conditions & MeSH terms

• Brain Edema
• Brain Neoplasms
• Diffuse Traumatic Cerebral Edema

Intervention

Drug:
• Progesteron
intramusculer progesterone

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Al Minya	Abohelal
Egypt	Faculty of Medicine	Minya	Abohelal

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With craniotomy-Related Adverse Events	Degree of microscopic cellular injury and brain odema in brain biopsy	3 months
Secondary	Number of Participants with neuronal deficit	Sensory, motor or autonomic dysfunction	2 months