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October 19, 2019
10/19/2019 1:00:00 PM - 10/19/2019 3:00:00 PM
Room W300
Perioperative Magnesium Sulfate May Improve Neurological Outcome Six Months after Brain Surgery
Isabel Gracia, M.D., Neus Fabregas, M.D.,Ph.D., Teresa Boget, M.D.,Ph.D., Laura Oleaga, M.D.,M.P.H., Georgina Casanovas, Ph.D., Paola Hurtado, M.D., Nicolas De Riva, M.D.,Ph.D., Roger Pujol, M.D., Joaquin Enseñat, M.D.,Ph.D., Ricard Valero, M.D.,M.P.H.
Hospital Clinic Barcelona University, Barcelona, Spain
Disclosures: I. Gracia: None. N. Fabregas: Funded Research; Self; Spanish National Grant.T. Boget: None.L. Oleaga: None.G. Casanovas: None.P. Hurtado: None.N. De Riva: None.R. Pujol: None.J. Enseñat: None.R. Valero: None.
Aim: Investigate the protective effect of perioperative intravenous magnesium sulfate administration in brain surgery patients. Outcome is determined by changes, from basal studies, in brain Magnetic Resonance Imaging (MRI) parameters and in the evolution of neuropsychological test. Patients and Method: Single-centre, randomized (Control [CON] and treatment group [MAG] stratified by type of surgery: tumors [TUM] and epilepsy [EPI]), double-blind, parallel and controlled by placebo (saline). Independent RCT (EudraCT: 011-006301-10; NCT01601314; Spanish Health Ministry National Grant nº EC11-165). IRB approval, informed consent. Infusion started at the arrival to the operating room and maintained 24 hours. MAG group received 4 g of Magnesium Sulfate in 100 mL of Saline in 20 minutes and 20 g in 24 h at 41.6 ML/h rate in Saline. CON group received the same saline volume without magnesium. Total intravenous anesthesia (propofol and remifentanil by a target control infusion system) was used. Demographic, biochemical, vital signs, intraoperative and postoperative complications were recorded. Presence of gliosis/edema, volume of residual cavity and contrast enhancement in RMI were measured at discharge and at 6 months. A 12 item battery test with standardized results was applied preoperatively at 6 and 12 months. “Mild impairment” was considered if a decline of 1-1.5 SD from baseline, “Moderate impairment” with a decline of 1,5-2 SD and “Severe impairment” with decline of 2 SD or more. The differences between treatment was estimated by means of Adjusted means (SE of means) and [95% CI] using Mixed Models for Repeated Measurements (MMRM) and Fisher exact test was performed for categorical data. Results: 51 patients were included: 16 EPI (7MAG, 9CON) and 35 TUM (18MAG, 17CON). There were no differences in the tumor malignancy within TUM group. Five patients did not complete the study, 3 in MAG/TUM group and 2 in CON/TUM group. Two patients died (one in each group). There were no safety issues in any included patient. At 6 months RMI [performed in 21 (84%) in MAG group and 23 (88.5%) in CON group] showed 11 patients (55%) in MAG group with gliosis/edema vs 19 (90.5%) in CON group (p=0.0144). Surgical cavity volume was 10.04 (95%CI 4.4-15.6) in MAG group vs 26.9 (95% CI13.8-39.9) in CON group (p=0.02). In tumor surgery patients 5 (33.3%) in MAG group had contrast enhancement vs 8 (80%) in CON group (p=0.0416).There were no differences between groups in the baseline Intelligence Test result. At 6 months in 7 battery test there was no cognitive impairment in any patient; in the remaining 4 test there were 3 patients with mild, 3 moderate and 2 with severe impairment. Analyzing the absolute standardized obtained values there was a clear trend of higher resolute behavior in MAG group vs CON group. Conclusion: In our RCT, intravenous administration of magnesium sulfate starting at the anesthesia induction of scheduled brain surgery resulted in macroscopic improvement in MRI parameters 6 months after surgery. A lower contrast enhancement in the tumor group, and lower gliosis/edema and residual volume cavity in epilepsy and tumor surgery treated patients may all be related to a best function of the blood-brain barrier. Moreover, neuropsychological test showed also better performance after six months in the group treated with magnesium, in both epilepsy and tumor surgery. Our results bring a change to our anesthesia practice in brain surgery, Sulfate magnesium administration may become a standard of care. However, a bigger study is needed to better support our opinion

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