Brain injury. Diffuse traumatic brain injury
Conditions
Interventions
Intervention 1: Intervention group: Patients in the drug group receive 200 mg of oral modafinil daily (Torrent Pharma, UK) dissolved in 10 cc of plain water at 9 am through a tube placed in the stomac
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
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, the consent of the patient's guardian or legal guardian Consent of the patient's guardian or legal guardian Age over 18 years and under 70 years Patients with moderate or severe head injury who are admitted to intensive care
Exclusion criteria
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 History of psychotropic and brain stimulant drug abuse and alcoholism History of severe liver failure History of seizures History of Anxiety Disorders Cardiac or respiratory recurrence in the first 6 days of hospitalization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unawareness condition. Timepoint: At intervals of one, three and six months after discharge from the hospital. Method of measurement: GOS-E (Glasgow Outcome Scale-Extended). | — |
Secondary
| Measure | Time frame |
|---|---|
| Agitation. Timepoint: Every 4 hour. Method of measurement: RASS (Richmond Agitation-Sedation Scale).;Level of Conciseness. Timepoint: Every 8 hours. Method of measurement: GCS(Glasgow Coma Score). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Zand
Shiraz University of Medical Sciences
Outcome results
None listed