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

January 12, 2018 updated by: Sara Varea
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum S100B protein
Time Frame: 2 hours after the end of the surgery
2 hours after the end of the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum S100B protein
Time Frame: 1 hour before surgery; daily postoperative until day 10.
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
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
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
within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative
Glasgow Outcome Scale
Time Frame: 6 and 12 month postoperative
6 and 12 month postoperative
Mortality
Time Frame: 6 and 12 month postoperative
6 and 12 month postoperative
Apolipoprotein E genotype
Time Frame: 1 hour before surgery
1 hour before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara Varea

Investigators

  • Principal Investigator: Neus Fabregas, MD PhD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAGNA
  • 2011-006301-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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