-
Study aim
-
Comparison of the effect of memantine and placebo on Glasgow Coma Scale (GCS) and serum levels of NSE in traumatic brain injury (TBI) patients
-
Design
-
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 60 patients (30 people in intervention group and 30 people in control group). The process of block random allocation of patients will be done with random allocation software (15 blocks of size four).
-
Settings and conduct
-
This study is a randomized controlled trial with placebo. The target population of this study will be brain injury patients who are hospitalized in the ICU of Imam Hospital in Sari. Participants, physicians, nurses, data collection assistants, and those evaluating the outcome are unaware of the type of intervention being assigned. The appearance and packaging of the drug and placebo are similar.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
TBI;
Primary GCS of 6-12;
At least 18 years old;
Gavage tolerance in the first 24 hours after traumatic brain injury;
Exclusion criteria:
Comorbidities, such as uncontrolled Diabetes mellitus (BS sugar more than 200 mg / dL at the time of admission);
Acute myocardial infarction in the last 48 hours, Acute or chronic renal failure; creatinine clearance less than 30 cc per minute; Liver disease, ALT, AST more than three to five times normal or having a previous history;
Autoimmune disorders ;
malignant diseases
-
Intervention groups
-
Intervention group: they will receive 30 mg of memantine tablets, twice a day, for a week within 24 hours of receiving. Control group: they will receive placebo tablets With the same dose and order of group 1. All patients will receive standard traumatic brain injury treatment.
-
Main outcome variables
-
GCS alertness score; NSE-specific enzyme enzyme neurons (NSE)