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Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients (MAGNA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01601314
First Posted: May 18, 2012
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica
  Purpose
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.

Condition Intervention Phase
Seizures (Incl Subtypes) Brain Tumor Drug: Magnesium Sulfate Other: Sodium Chloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

Resource links provided by NLM:


Further study details as provided by Sara Varea, Fundació Clínic per la Recerca Biomèdica:

Primary Outcome Measures:
  • Serum S100B protein [ Time Frame: 2 hours after the end of the surgery ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: October 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Spain
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Sara Varea
Investigators
Principal Investigator: Neus Fabregas, MD PhD Hospital Clinic of Barcelona
  More Information

Responsible Party: Sara Varea, Clinical Research Manager, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01601314     History of Changes
Other Study ID Numbers: MAGNA
2011-006301-10 ( EudraCT Number )
First Submitted: May 10, 2012
First Posted: May 18, 2012
Last Update Posted: August 3, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents


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