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Original Article
Randomized controlled trial of magnesium sulphate in severe closed traumatic
brain injury
SS Dhandapani M Ch, Aditya Gupta M Ch, S Vivekanandhan* M Sc B S Sharma
M Ch, AK Mahapatra M Ch
Departments of Neurosurgery and Neurobiochemistry*, Neurosciences centre
All India Institute of Medical Sciences, New Delhi
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Magnesium decline is likely to play an important role in the pathogenesis
of Traumatic Brain Injury (TBI). This study was undertaken to test
the therapeutic efficacy and safety of parenterally administered
Magnesium sulphate (MgSO4) in patients of severe closed TBI. Adult
patients admitted within 12 hours of closed TBI with Glasgow coma
score 5 to 8 fulfilling eligibility criteria were randomized to
two groups, one group receiving ‘standard care’ and the other, MgSO4
in addition as per the Pritchard regimen. The outcome measures were
Glasgow outcome scale at 3 months and other relevant clinical parameters.
Seventy patients were randomized after obtaining informed consent,
and 30 in each group remained in the study till 3 months. Favorable
outcome was observed in 22 out of 30 patients (73.3%) who had received
MgSO4, as compared with 12 out of 30 (40%) in control group. Univariate
analysis revealed an odds ratio (OR) of 4.13 (95% CI 1.39-12.27)
and the P value was 0.009. In the logistic regression analysis,
the adj. OR was 4.24 (95% CI 1.1- 16.36) and the P value was 0.036.
The secondary outcomes analyzed in MgSO4 group showed significant
difference with respect to intra-operative brain swelling at the
end of surgical decompression and mortality at 1 month. No significant
adverse effects were observed. Parenteral MgSO4 appears to have
some favorable influence on mortality and intra-operative brain
swelling without any significant adverse effects..
Keywords : Severe traumatic brain
injury, Magnesium sulphate, Pritchard regimen, Outcome
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Address for correspondence:
Dr. Aditya Gupta Assoc. Professor,
Dept. of Neurosurgery,
AIIMS, New Delhi -110029.
Ph: (011) 26588700 Extn. 4914
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