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IRCT20141209020258N128 IRCT 2020-01-10 Arak University of Medical Sciences Evaluation of the effect of Methylphenidate on consciousness in patients ‎with brain damage in ICU Evaluation of the effect of Methylphenidate on consciousness in patients ‎with brain damage in ICU 2018-04-30 anticipated 90 Complete https://irct.ir/trial/44246 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in two groups A and B.‏ In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor. 3 Brain damage. Intervention 1: Intervention group: Patients will receive 0.3 milligram in kilogram methylphenidate daily in two divided doses of 6 morning and 2 afternoon. Intervention 2: Control group: Patients will not receive anything. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: Researcher in university Conditions: If there are additional questions Where to obtain: Dr Behnam Mahmodie How to obtain: They have to write letters to the professors and the university Comments:
public Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 68 3222 2003 alikamaliir@yahoo.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) A level of consciousness less than 10 Being intuitive Ages between 16 and 50 years History of brain injury Absence of spacer lesion in brain scan (hematoma, tumor) No history of seizures No addiction to psychotropic substances and drugs No history of amphetamine use No history of hypertension, ischemic heart disease and diabetes mellitus Heart rate less than 120 times per minute 16 years 50 years Both Seizure Arrhythmia Death P11.2 Unspecified brain damage due to birth injury Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive 0.3 milligram in kilogram methylphenidate daily in two divided doses of 6 morning and 2 afternoon. Control group: Patients will not receive anything. Level of consciousness. Timepoint: daily to clearance time. Method of measurement: Glasgow coma scale. Illness severity. Timepoint: First and third day and time of discharge. Method of measurement: Apache score. Arak University of Medical Sciences Approved 2018-04-29 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)