Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the relationship between magnesium sulphate administration and levels of S100B protein in serum of patients undergoing supratentorial brain parenchymal resection.

Official Title
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Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

Conditions
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Seizures (Incl Subtypes), Brain Tumor

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Other: Sodium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females older than 18 years. Undergoing supratentorial parenchyma resection surgery. Capable of collaborate on probes and explorations included in the study. Signature the written informed consent form. Exclusion Criteria: Life expectancy less than 12 months due to the suspected histological type of tumour. Hypothalamic-pituitary axis illness. Presence of Melanoma previously. Glomerular filtration rate less than 60 mL/min. Thyroid or parathyroid glands pathology. Myasthenia gravis. Respiratory depression. Pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: magnesium sulphate<br>The patients who are going to receive Magnesium Sulphate | Drug: Magnesium Sulfate<br>* At the beginning of the neurosurgery, the subjects are going to receive one 4gr bolus in Sodium Chloride 100 mL, lasting 20 minutes, intravenously. After that, a intravenously perfusion of Magnesium Sulfate 20 gr, in Sodium Chloride 1000 mL, lasting 24 hours, will be started.<br>|
| Placebo Comparator: Control<br>Patients who are going to receive Sodium Chloride 0.9% | Other: Sodium Chloride<br>* At the beginning of the neurosurgery, the subjects are going to receive a bolus of Sodium Chloride 100 mL, lasting 20 minutes, intravenously. After that, a intravenously perfusion of Sodium Chloride 1000 mL, lasting 24 hours, will be started.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum S100B protein |  | 2 hours after the end of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum S100B protein |  | 1 hour before surgery; daily postoperative until day 10. | 
| Serum Specific Neuronal Enolase (SNE) |  | 1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10 | 
| Improvement on Magnetic Resonance Imaging |  | within the month prior to surgery; early postoperative; 6 months postoperative | 
| Improvement on Neuropsychological Assessment |  | within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative | 
| Glasgow Outcome Scale |  | 6 and 12 month postoperative | 
| Mortality |  | 6 and 12 month postoperative | 
| Apolipoprotein E genotype |  | 1 hour before surgery |