Patient who are going to be under cerebral parenchyma resection, due to epilepsy or tumor MedDRA version: 14.1 Level: HLGT Classification code 10039911 Term: Seizures (incl subtypes) System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: LLT Classification code 10006153 Term: Brain tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Magnesio (sulfato de) Lavoisier 15%
Product Name: Magnesium sulfate
Pharmaceutical Form: Solution for injection
CAS Number: 7487-88-9
Other descriptive name: MAGNESIUM SULFATE
Concentratio
Sponsors
Fundació Clinic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
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 |
|---|---|
| Main Objective: Determine the relationship between Magnesium Sulphate administration and levels of S100B protein in serum of patiens undergoing supratentorial brain parenquimal resection;Secondary Objective: Determine the relationship between Magnesium Sulphate administration and levels of S100B protein and Specific Neuronal Enolase (SNE) at different points of the postoperative course. Determine the relationship between Magnesium Sulphate administration and improvement on Magnetic Resonance Imaging at early postoperative moment and 6 months after surgery, related to preoperative imaging. Determine the relationship between Magnesium Sulphate administration and improvement on Neuropsychological Assessment at early postoperative moment and 1, 6 and 12 months after surgery. Determine the relationship between Magnesium Sulphate administration and Glasgow Outcome Scale (GOS) and Mortality at 6 and 12 months after surgery. Determine how Apolipoprotein E genotype affects neurological outcome;Primary end point(s): Serum S100B protein level?s of patients undergoing supratentorial brain parenquimal resection;Timepoint(s) of evaluation of this end point: 2 hours after the end of the surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Levels of S100B protein and Specific Neuronal Enolase (SNE). Improvement on Magnetic Resonance Imaging. improvement on Neuropsychological Assessment. Glasgow Outcome Scale (GOS) and Mortality. Apolipoprotein E genotype.;Timepoint(s) of evaluation of this end point: It depends on the type of end point: S100B protein: pre-surgery; daily postoperative until day 10. SNE: pre-surgery; 2 hours after end of surgery; every 48 hours until day 10. RMI: pre-surgery; early postoperative; 6 months postoperative. Neuropsichologycal assessment: pre-surgery; early postoperative; 1, 6 and 12 months postoperative. GOS: 6 and 12 month postoperative. Mortality: 6 and 12 month postoperative. Apolipoprotein E genotype: pre-surgery. | — |
Countries
Spain
Contacts
Public ContactCTU
Clinical Trials Unit
Outcome results
None listed