Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

Sara Varea55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Seizures (Incl Subtypes)Brain Tumor

Interventions

Magnesium SulfateDRUG

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.

Sodium ChlorideOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clinic of Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

Serum S100B protein

Time frame: 2 hours after the end of the surgery

Secondary Outcomes

Serum S100B protein

Time frame: 1 hour before surgery; daily postoperative until day 10.

Serum Specific Neuronal Enolase (SNE)

Time frame: 1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10

Improvement on Magnetic Resonance Imaging

Time frame: within the month prior to surgery; early postoperative; 6 months postoperative

Improvement on Neuropsychological Assessment

Time frame: within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative

Glasgow Outcome Scale

Time frame: 6 and 12 month postoperative

Mortality

Time frame: 6 and 12 month postoperative

Apolipoprotein E genotype

Time frame: 1 hour before surgery

Data from ClinicalTrials.gov

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