Cytoprotective Effect and Clinical Outcome of Perioperative Progesterone in Brain Tumors. A Novel Randomized Mono-Centeric Microscopic Evidence Based Research.

Abstract

\n Objectives.The primary end-point of the current study was to to provide contemporary estimate about both cytoplasmic and nuclear effects of intramuscular progesterone therapy prior to craniotomy. Secondary end-points were to track post-operative course and short term (3 months) neurological sequele.Measurments.Cellular neuronal microscopic examination by immuno-histochemistry (Progesterone receptor density ) and by H&E. Allred score for nuclear staining for PR receptors . Post-operative course included time to wean from mechanical ventilation (hours), Length of ICU stay (days) and brain neuro-imaging by brain CT). Short term outcome included sensory, motor and autonomic assessment. Patients.Two hundred fifty two (252) adult patients of both sexes aged 18–60 years, American society of anesthesia (ASA class І-ІІ ) candidate for intra-parenchymal intra-axial elective brain tumors resection , Excluded candidates included refusal to sign document for intervention, urgent craniotomy, history of endometrial or ovarian neoplasia, redo craniotomy, stented coronary arteries or history of deep venous thrombosis. Design. This research was a randomized, double-blind, placebo controlled single center study. Intervention. Two groups, the control group and Progesterone (PR) group. PR group received 1mg/ kg intramuscular progesterone five days before and five days after craniotomy, while Control group received intramuscular isotonic saline daily, five days before and five days after surgery.Setting.Fixtures performed in Minia university hospital, Neurosurgery operative theatre, Floor two (non trauma floor). The study was registered in local ethical committee on April 2020. First patient enrollment was on first of June 2020 and the patient allocation in the rank ended on 30 of December 2020. Main resultsProgesterone therapy successfully increased expression of active nuclear PR receptors on oligodendrocytes and astrocytes, provided cytoplasmic and nuclear neuro-quiescence. Progesterone gave better neurological outcome on 3 month follow- up.Conclusions.Neuronal biopsy examination represented a leap in confirming anti-neuro-inflammatory action offered by progesterone.Name of the registry. Clinical trial .gov.Trial registration number. NCT04414020.Date of registration. 30 of May 2020.URL of trial registry record. ttps://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009WLW&selectaction=Edit&uid=U0004XC5&ts=2&cx=-vrqng9