Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

Phase 3

Completed

• Conditions: Seizures (Incl Subtypes); Brain Tumor
• Interventions: Other: Sodium Chloride; Drug: Magnesium Sulfate

• Registration Number: NCT01601314
• Lead Sponsor: Sara Varea

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-18
• Study Start: 2012-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sodium Chloride	Patients who are going to receive Sodium Chloride 0.9%
magnesium sulphate	Magnesium Sulfate	The patients who are going to receive Magnesium Sulphate

Primary Outcome Measures

Name	Time	Method
Serum S100B protein	2 hours after the end of the surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain