In this study effect of treatment with Magnesium as a neuroprotective agent in brain surgery would be evaluated. In this double blind, placebo controlled, randomized clinical trial study a group of 60 craniotomy surgery patients admitted to Sina Hospital neurosurgery ward will participate. Patients with renal insufficiency, heart failure or any contraindications for magnesium or previous magnesium intake would be excluded. Patients will be randomly assigned to control and intervention groups each consisted of 30 patients. Intervention group will receive 5 grams of magnesium sulfate equal to 525 milligrams of elemental magnesium in 1 liter of saline solution over 6 hours infusion daily for 2 day before and during craniotomy surgery. Control group will receive normal saline as placebo in same manner. Anti-inflammatory factor CRP and S100B protein will be measured as brain injury factors before intervention with drug or placebo then at the beginning and 24 hours after Craniotomy surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204159475N1
Registration date:2013-07-16, 1392/04/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
vise-challenger of research, Tehran University of Medical Sciences.
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of magnesium sulfate infusion with placebo on prevention of brain injury in craniotomy surgery patients
Public title
Evaluation of Magnesium effects on brain tumor surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: eligible patients for brain tumor craniotomy
exclusion criteria of the study:
- creatinine greater than 1.5 mg / dl
- Renal failure and nephrotic syndrome
- Heart rate below 60 beats per minute
- Severe metabolic disorders
- Coagulation disorders (coagulopathy)
- Myasthenia Gravis
- Previous use of magnesium
- Diabetes Mellitus
- Age over 60 or under 18
- GCS score less than 6
- Major cardiopulmonary disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th floor, Tehran University of Medical Sciences central building, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
2132/130/د/91
Health conditions studied
1
Description of health condition studied
neoplasm of brain
ICD-10 code
C71.9
ICD-10 code description
Malignant neoplasm of brain (unspecified)
Primary outcomes
1
Description
CRP
Timepoint
before intervention, before surgery, after surgery
Method of measurement
ELISA kit
2
Description
S100b protein
Timepoint
before intervention, before surgery, after surgery
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Neurological adverse reactions
Timepoint
After surgery up to 6 month
Method of measurement
Clinical evaluation by neurosurgeon or neurologist
2
Description
Pain and bleeding during and after surgery
Timepoint
During and after surgery
Method of measurement
Clinical evaluation by anesthesiologist
Intervention groups
1
Description
5 grams of magnesium sulfate in 1 liter of normal saline via intravenous infusion over 6 hours daily for 2 days before surgery and 5 grams of magnesium sulfate in 1 liter of normal saline via intravenous infusion over 6 hours during surgery
Category
Treatment - Drugs
2
Description
Infusion of 1 liter of normal saline over 6 hours daily for 2 days before surgery and infusion of 1 liter of normal saline over 6 hours during surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery ward of Sina Hospital
Full name of responsible person
Abbas Amir Jamshidi
Street address
Sina Hospital, Emam Khomeini Square.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vise-Challenger of research of Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central Building of University, Ghods Avenue, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vise-Challenger of research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Mohammad Reza Khajavi
Position
Associate Professor/Anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini Avenue, Hasan Abad Square, Sina Hospital
City
Tehran
Postal code
Phone
+98 21 6670 1041
Fax
Email
khajavim@sins.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Mohamad Reza Khajavi
Position
Associate Professor/Anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini Avenue, Hasan Abad Square
City
Tehran
Postal code
Phone
+98 21 6670 1041
Fax
Email
khajavim@sins.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahador Mirrahimi
Position
Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
16th Azar Street, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
mirrahimi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)