Brain Tumor, Seizures (Incl Subtypes)
Conditions
Brief summary
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.
Interventions
DRUGMagnesium Sulfate
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.
OTHERSodium Chloride
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.
Sponsors
Sara Varea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum S100B protein | 2 hours after the end of the surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Serum S100B protein | 1 hour before surgery; daily postoperative until day 10. |
| Mortality | 6 and 12 month postoperative |
| Apolipoprotein E genotype | 1 hour before surgery |
| Glasgow Outcome Scale | 6 and 12 month postoperative |
Countries
Spain
Outcome results
None listed