Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

Brain Tumor Clinical Trial

— MAGNA  

Official title:

Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601314
• Other study ID #: MAGNA
• Secondary ID: 2011-006301-10
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2012
• Last updated: January 12, 2018
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Tumor
• Seizures
• Seizures (Incl Subtypes)

Intervention

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.

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sara Varea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum S100B protein		2 hours after the end of the surgery
Secondary	Serum S100B protein		1 hour before surgery; daily postoperative until day 10.
Secondary	Serum Specific Neuronal Enolase (SNE)		1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10
Secondary	Improvement on Magnetic Resonance Imaging		within the month prior to surgery; early postoperative; 6 months postoperative
Secondary	Improvement on Neuropsychological Assessment		within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative
Secondary	Glasgow Outcome Scale		6 and 12 month postoperative
Secondary	Mortality		6 and 12 month postoperative
Secondary	Apolipoprotein E genotype		1 hour before surgery