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IRCT20141009019470N105 IRCT 2021-01-25 Shiraz University of Medical Sciences 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 of Rajaee Trauma Center in 1399-1400 2021-02-02 anticipated 314 Complete https://irct.ir/trial/53612 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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.). 2-3 Brain injury. 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 stomach. Intervention 2: 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. The placebo is dissolved in 10 cc of plain water and patients receive the placebo at 9 am through a tube inserted into the stomach. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against the policies of our center.
public Zahra Zand
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 zandfarid@yahoo.com Shiraz University of Medical Sciences scientific Farid Zand
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 zandfarid@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both 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 S06.2 Diffuse traumatic brain injury Treatment - Drugs Placebo 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 stomach 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. The placebo is dissolved in 10 cc of plain water and patients receive the placebo at 9 am through a tube inserted into the stomach. 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). 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). Shiraz University of Medical Sciences Approved 2021-01-06 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)