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IRCT20211211053353N1 IRCT 2022-01-12 Tehran University of Medical Sciences Evaluation of the effect of melatonin in preventing delirium in patients after neurosurgery Evaluation of the effect of oral melatonin administration in preventing delirium in patients after neurosurgery 2022-01-21 anticipated 38 Complete https://irct.ir/trial/60562 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: Simple randomization by table of random numbers. This will be done by Computerized Random number generator. The information will enter the computer systems and the system will classify the information completely randomly, Blinding description: Participants and clinical caregivers are blind in this study, so that none of them knows who is in the main group and the drug and who is in the placebo group. 2-3 delirium. Intervention 1: Intervention group: Melatonin, 5mg, twice: the night before surgery and 90 minutes before surgery, taken orally. Intervention 2: Control group: placebo. Yes - There is a plan to make this available What will be shared: Items published in the article are available When: After the publication of the study results To whom: Clinical Pharmacists Neurologists Conditions: Contact the responsible person Where to obtain: Contact the responsible person How to obtain: The information is published after the results are completed and analyzed Comments:
public Atefeh Karimi
No.5,Aghamajidi Ali,Avini Ave,Hadisaee Square,Rey
Tehran Iran (Islamic Republic of) 1843635862 +98 21 5597 5268 ati.karimi97@gmail.com Tehran University of Medical Sciences scientific Atefeh Karimi
No.5,Aghamajidi Ali,Avini Ave,Hadisaee Square,Rey
Tehran Iran (Islamic Republic of) 1843635862 +98 21 5597 5268 ati.karimi97@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients undergoing degenerative spine surgery. 65 years no limit Both Patients with a history of alcoholism Dementia Patients with brain accidents such as stroke, bleeding, infection Taking medications such as:Anticonvulsants / Antidepressants / Antihistamines / Parkinson's / Antipsychotics / Benzodiazepines 6D70 Delirium is characterized by a disturbance of attention, orientation, and awareness that develops within a short period of time, with transient symptoms that may fluctuate depending on the underlying causal condition or etiology. Delirium often includes d Treatment - Drugs Placebo Intervention group: Melatonin, 5mg, twice: the night before surgery and 90 minutes before surgery, taken orally Control group: placebo Percentage of people who develop delirium after neurosurgery. Timepoint: After surgery and 1,2,3 days after surgery. Method of measurement: questionnaire Confusion Assessment Method for the ICU (CAM-ICU). Tehran University of Medical Sciences Approved 2022-01-04 Ethics Committee of Tehran University of Medical Sciences No.5,Aghamajidi Ali,Avini Ave,Hadisaee Square,Rey Tehran Tehran Iran (Islamic Republic of)