The comparison between oral modafinil and placebo to accelerate the rate of improvement in the level of consciousness in adult patients with moderate or severe acute traumatic brain injury admitted in intensive care units of Rajaee Trauma Center in 1399-1400

The comparison between oral modafinil and placebo to accelerate the rate of improvement in the level of consciousness in adult patients with moderate or severe acute traumatic brain injury admitted in intensive care units

Double-blind randomized clinical trial

Intervention group: Patients in the drug group receive 200 mg of oral modafinil daily (Torrent Pharma, UK) at 9 am. Control group: In order not to inform patients, physicians, nurses and the entire treatment team about assigning patients to two groups, placebo is prepared with the help of the pharmacosynthetic department of the School of Pharmacy in a completely similar way in terms of color, size and weight .patients receive the placebo at 9 am.

Inclusion Criteria: Patients who have a GCS score between 6 and 12 at the time of initiation of NG tube feeding in the ICU, Head AIS score above 3 on the first day of ICU stay, the AIS score of the other parts below 3 on the first day of ICU stay, Age over 18 years and under 70 years, Patients with moderate or severe head injury who are admitted to intensive care. Exclusion Criteria: Severe side effects such as severe agitation or anaphylactic reaction to modafinil ,Occurrence of seizures, Incidence of death or brain death, multiple trauma, Injury Severity Score less than 20.

Intervention group: Patients in the drug group receive 200 mg of oral modafinil daily (Torrent Pharma, UK) at 9 am. Control group: In order not to inform patients, physicians, nurses and the entire treatment team about assigning patients to two groups, placebo is prepared with the help of the pharmacosynthetic department of the School of Pharmacy in a completely similar way in terms of color, size and weight .patients receive the placebo at 9 am.

Unawareness condition, Agitation

Patients are randomly divided into two groups of drugs and placebo. Randomization by block randomization method in 4.6.8 blocks and using random numbers taken from the site https://www.sealedenvelope.com. A person who examines patients for inclusion is unaware of the random patient allocation table. Information about each patient is collected from the time of the examination in terms of enrollment conditions until each of the following outcomes is reached: The end of the follow-up period or death or withdrawal from the study, whichever occurs sooner, will be recorded and reported.

The patient and the person measuring and determining the outcomes do not know which group of drugs or placebos the patient is in. In order not to inform patients, physicians, nurses and the entire treatment team about assigning patients to two groups, placebos are prepared with the help of the pharmacosynthetic department of the School of Pharmacy in a completely similar way in terms of color, size and weight. People in the drug group are given 200 mg of oral modafinil (Torrent Pharma, UK) daily, dissolved in 10 cc of plain water, at 9 a.m. through a tube in the stomach for one week. . Patients' GCS (Glasgow Coma Score) score is recorded every 8 hours. (The highest GCS score is recorded within 8 hours.)

It is against the policies of our center.