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IRCT20141209020258N190 IRCT 2023-10-12 Arak University of Medical Sciences Evaluation of the effect of Modafinil on consciousness in patients with brain damage in Intensive care unit Evaluation of the effect of Modafinil on consciousness in patients with brain damage in Intensive care unit 2023-10-23 anticipated 126 Complete https://irct.ir/trial/73017 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: In this study, the supervisor knows about the grouping and prescribes the drugs for the patients, and the interns do not know about the prescribed drugs, and the follow-up of the patients is with the interns, and the analyst does not know about the grouping, and as a result, the study will be double-blind. 2-3 Brain damage. 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Behnam Mahmodie
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mahmodie@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) 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 16 years 50 years Both arrhythmia Emergence of evidence of drug sensitivity Death Lack of consent of the patient to participate in the study P11.1 Other specified brain damage due to birth injury Treatment - Drugs Treatment - Drugs Intervention group: Modafinil drug will be administered orally or by gavage in the amount of 100 mg twice a day. Control group: will receive placebo twice a day. 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. Arak University of Medical Sciences Approved 2023-03-05 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)