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Study aim
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Evaluation the effect of N-acetylcysteine as a neuroprotective in traumatic brain injury patients with moderate to severe consciousness level admitted to intensive care unit.
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Design
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Randomised, controlled, parallel group trial with blinded outcome assessment. Randomisation was centralised with simple randomization with random number tables
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Settings and conduct
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Twenty eight patients in age group 18 to 65 years are randomly divided by random number tables into intervention (N-acetylcysteine) and control groups (n=14 cases). Researchers responsible for data collection and analyses are blind to the groups allocation.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria are age range 18 – 65 year, consciousness level 9-12 based on GCS and transferred to intensive care unit less than 24 hours after trauma; The exclusion criteria are allergic reaction to N-acetylcysteine, stay in intensive care unit less than 72 hours, pregnant patients, associated spinal cord injury, craniotomy and history of autoimmune diseases.
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Intervention groups
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In the Intervention group, oral N-acetylcysteine with dose of 600 mg will be prescribed twice a day. In the control group, placebo (medical plaster powder) with dose of 600 mg will be prescribed twice a day.
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Main outcome variables
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Consciousness level based on GCS will recorded upon arrival, two days, 1, 2, 3 and 4 weeks after the drug administration and will compared between the two groups. Duration of hospitalization, the time required for mechanical ventilation and rate of mortality will compared between the two groups.