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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006301-10 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnesium sulphate | Experimental | The patients who are going to receive Magnesium Sulphate |
|
| Control | Placebo Comparator | Patients who are going to receive Sodium Chloride 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum S100B protein | 2 hours after the end of the surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neus Fabregas, MD PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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|
| Sodium Chloride | Other | 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. |
|
| 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 |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |