Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Seizures (Incl Subtypes) Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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magnesium sulphate

The patients who are going to receive Magnesium Sulphate

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type 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.

Control

Patients who are going to receive Sodium Chloride 0.9%

Group Type PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No