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IRCT20220924056025N1 IRCT 2022-10-09 Qazvin Medical Sciences Research Deputy Investigating the effect of methylphenidate on increasing the level of consciousness in patients with hypoxic ischemic encephalopathy Investigating the effect of methylphenidate on increasing the level of consciousness of patients with hypoxic ischemic encephalopathy in the special care departments of Bo Ali Qazvin Hospital during one year. 2022-11-21 anticipated 48 Complete https://irct.ir/trial/66147 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are selected and included in the study using the available sampling method based on the entry and exit criteria. To assign patients to treatment groups, block randomization method is used so that the number of samples assigned to each of the two treatment groups is balanced. According to the sample size of 24 in each group, 12 blocks of 4 random permutations of two treatment methods A, B (in the form of AABB) are needed. Random allocation software version 2 is used to create random permutations of 4 (random blocks of 4). The output of the software is alternating random combinations of 4 of the two treatment methods, based on which the patients are assigned to one of the two treatment groups, Blinding description: A placebo is prepared by a pharmaceutical company similar to methylphenidate tablets at the request of the researcher. After that, the placebo and the drug are coded by a non-researcher observer, and the coded drugs are provided to the researcher. The drug code is provided to the researcher at the end of the study. . the standard treatment, while the patient nurse researcher does not know which group the patient is in. 3 Hypoxic ischemic encephalopathy. Intervention 1: Intervention group: this group receives 10 mg methylphenidate tablets once a day in the morning until the day the patient stays in the ICU (maximum one month) in the form of gavage. Intervention 2: Control group: The control group receives daily placebo in the form of gavage in the morning until the day the patient stays in the ICU (maximum one month). Yes - There is a plan to make this available What will be shared: Individual data in accordance with the approval of the ethics committee Primary and secondary outcomes When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Physicains working in the special care department of hospitals Conditions: Contact to the researcher for determining the examples Where to obtain: Dr. Kian Abed Khorasani, Qazvin University of Medical Sciences, contact number 09907485823, email kianabed2495@gmail.com How to obtain: Direct contact with the researcher, investigation and response within a maximum of two weeks, in case of non-availability, contact with the Research Vice-Chancellor of Qazvin University of Medical Sciences Comments:
public Kian Abed Khorasani
No. 115, Golha Blvd. 406 East, Karaj Phase Four, Mehr City
Qavzin Iran (Islamic Republic of) 3419915315 +98 28 3333 6001 kianabed2495@gmail.com Qazvin University of Medical Sciences scientific Kian Abed Khorasani
No. 115, Golha Blvd. 406 East, Karaj Phase Four, Mehr City
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3333 2930 kianbed2495@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients hospitalized in the intensive care unit with the diagnosis of HIE hypoxic ischemic encephalopathy, Aged between 18 and 65 years Both sexes (male and female) With some degree of reduced level of consciousness. 18 years 65 years Both Patients with a history of epilepsy Patients with high blood pressure that is newly discovered and not treated or controlled Patients with Cardiac ischemia and arrhythmia that are newly discovered and not treated or controlled, Patients with deafness Patients with rapid changes in vital signs and unstable hemodynamics Patients with multiple organ failure Patients with hyperthyroidism pregnancy Drug addiction Secondary surgery Reluctance to attend the investigation based on the opinion of the patient's legal guardian P91.6 Hypoxic ischemic encephalopathy [HIE] Treatment - Other Treatment - Other Intervention group: this group receives 10 mg methylphenidate tablets once a day in the morning until the day the patient stays in the ICU (maximum one month) in the form of gavage. Control group: The control group receives daily placebo in the form of gavage in the morning until the day the patient stays in the ICU (maximum one month). Average level of consciousness based on 4 Score criteria. Timepoint: Every three days for a month. Method of measurement: Criterion 4 Score in ICU. Average biological indicators of systole and diastole blood pressure. Timepoint: Every three days for a maximum of one month. Method of measurement: Recording of ICU patient monitoring every three days for a maximum of one month. Average biological index of arterial oxygen saturation percentage. Timepoint: Every three days for a maximum of one month. Method of measurement: Recording of ICU patient monitoring every three days for a maximum of one month. Average biological index of heart rate. Timepoint: Every three days for a maximum of one month. Method of measurement: Recording of ICU patient monitoring every three days for a maximum of one month. Qazvin Medical Sciences Research Deputy Approved 2020-09-18 Ethic committee of Qazvin University of Medical Science No115,East406,Phase 4 Mehrshahr ,Karaj Qazvin Qazvin Iran (Islamic Republic of)