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
- Conditions
- Brain injury.Diffuse traumatic brain injuryS06.2
- Registration Number
- IRCT20141009019470N105
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 314
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nawareness 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 Outcome Measures
Name Time Method 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).