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

This study is currently recruiting participants.
Verified April 2014 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01601314
First received: May 10, 2012
Last updated: April 8, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Serum S100B protein [ Time Frame: 2 hours after the end of the surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum S100B protein [ Time Frame: 1 hour before surgery; daily postoperative until day 10. ] [ Designated as safety issue: No ]
  • Serum Specific Neuronal Enolase (SNE) [ Time Frame: 1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10 ] [ Designated as safety issue: No ]
  • Improvement on Magnetic Resonance Imaging [ Time Frame: within the month prior to surgery; early postoperative; 6 months postoperative ] [ Designated as safety issue: No ]
  • Improvement on Neuropsychological Assessment [ Time Frame: within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative ] [ Designated as safety issue: No ]
  • Glasgow Outcome Scale [ Time Frame: 6 and 12 month postoperative ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 6 and 12 month postoperative ] [ Designated as safety issue: No ]
  • Apolipoprotein E genotype [ Time Frame: 1 hour before surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601314

Contacts
Contact: Neus Fabregas, MD PhD +34932275400 FABREGAS@clinic.ub.es
Contact: Isabel Gracia, MD +34932245400 IGRACIA@clinic.ub.es

Locations
Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Neus Fabregas, PhD MD       FABREGAS@clinic.ub.es   
Contact: Isabel Gracia, MD       IGRACIA@clinic.ub.es   
Principal Investigator: Neus Fabrega, PhD MD         
Sponsors and Collaborators
Sara Varea
Investigators
Principal Investigator: Neus Fabregas, MD PhD Hospital Clinic of Barcelona
  More Information

No publications provided

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
Study First Received: May 10, 2012
Last Updated: April 8, 2014
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on April 20, 2014