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Completed

NCT Number: NCT01601314

Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

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.

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Key information

Conditions

Seizures (Incl Subtypes) Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulfate

Drug

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.

Sodium Chloride

Other

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 outcomes

  1. Serum S100B protein

    Time frame: 2 hours after the end of the surgery

Secondary outcomes

  1. Serum S100B protein

    Time frame: 1 hour before surgery; daily postoperative until day 10.

  2. Serum Specific Neuronal Enolase (SNE)

    Time frame: 1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10

  3. Improvement on Magnetic Resonance Imaging

    Time frame: within the month prior to surgery; early postoperative; 6 months postoperative

  4. Improvement on Neuropsychological Assessment

    Time frame: within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative

  5. Glasgow Outcome Scale

    Time frame: 6 and 12 month postoperative

  6. Mortality

    Time frame: 6 and 12 month postoperative

  7. Apolipoprotein E genotype

    Time frame: 1 hour before surgery

Sponsors and collaborators

Lead sponsor

Sara Varea

Other

Registry information

Acronym: MAGNA

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 18, 2012
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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