Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients (MAGNA)
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|ClinicalTrials.gov Identifier: NCT01601314|
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Seizures (Incl Subtypes) Brain Tumor||Drug: Magnesium Sulfate Other: Sodium Chloride||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: magnesium sulphate
The patients who are going to receive Magnesium Sulphate
Drug: Magnesium 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.
Placebo Comparator: Control
Patients who are going to receive Sodium Chloride 0.9%
Other: Sodium 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.
- Serum S100B protein [ Time Frame: 2 hours after the end of the surgery ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601314
|Hospital Clinic of Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Neus Fabregas, MD PhD||Hospital Clinic of Barcelona|