Back to resultsPerioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients (MAGNA)
Primary Purpose
Seizures (Incl Subtypes), Brain Tumor
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Magnesium Sulfate
Sodium Chloride
Sponsored by
About this trial
This is an interventional prevention trial for Seizures (Incl Subtypes)
Eligibility 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.
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.
Sites / Locations
- Hospital Clinic of Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
magnesium sulphate
Control
Arm Description
The patients who are going to receive Magnesium Sulphate
Patients who are going to receive Sodium Chloride 0.9%
Outcomes
Primary Outcome Measures
Serum S100B protein
Secondary Outcome Measures
Serum S100B protein
Serum Specific Neuronal Enolase (SNE)
Improvement on Magnetic Resonance Imaging
Improvement on Neuropsychological Assessment
Glasgow Outcome Scale
Mortality
Apolipoprotein E genotype
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601314
Brief Title
Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
Acronym
MAGNA
Official Title
Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Varea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures (Incl Subtypes), Brain Tumor
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
magnesium sulphate
Arm Type
Experimental
Arm Description
The patients who are going to receive Magnesium Sulphate
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients who are going to receive Sodium Chloride 0.9%
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sodium Chloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum S100B protein
Time Frame
2 hours after the end of the surgery
Secondary Outcome Measure Information:
Title
Serum S100B protein
Time Frame
1 hour before surgery; daily postoperative until day 10.
Title
Serum Specific Neuronal Enolase (SNE)
Time Frame
1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10
Title
Improvement on Magnetic Resonance Imaging
Time Frame
within the month prior to surgery; early postoperative; 6 months postoperative
Title
Improvement on Neuropsychological Assessment
Time Frame
within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative
Title
Glasgow Outcome Scale
Time Frame
6 and 12 month postoperative
Title
Mortality
Time Frame
6 and 12 month postoperative
Title
Apolipoprotein E genotype
Time Frame
1 hour before surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neus Fabregas, MD PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
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