Brain damage. Other specified brain damage due to birth injury
Conditions
Interventions
Intervention 1: Intervention group: Modafinil drug will be administered orally or by gavage in the amount of 100 mg twice a day. Intervention 2: Control group: will receive placebo twice a day.
Sponsors
Arak University of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: GCS less than 10 Intubation Between 16 and 50 years History of brain injury Absence of space-occupying lesion in brain CT scan (hematoma, tumor) No history of seizures No addiction to psychoactive substances and narcotics No history of hypertension, ischemic heart disease and diabetes mellitus Heart rate less than 120 beats per minute
Exclusion criteria
Exclusion criteria: arrhythmia Emergence of evidence of drug sensitivity Death Lack of consent of the patient to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time required until ventilator isolation. Timepoint: End of study. Method of measurement: Clinical observation.;Level of consciousness. Timepoint: On consecutive days from the first day of hospitalization to the day of discharge. Method of measurement: Glasgow coma scale.;Agitation intensity. Timepoint: On consecutive days from the first day of hospitalization to the day of discharge from the intensive care unit. Method of measurement: Richmond Agitation Sedation Score.;Mortality. Timepoint: End of study. Method of measurement: Clinical observation.;The number of days of hospitalization in the intensive care unit. Timepoint: End of study. Method of measurement: Clinical observation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Hesamedin Modir
Arak University of Medical Sciences
Outcome results
None listed