]>
IRCT20141209020258N114 IRCT 2019-07-03 Arak University of Medical Sciences Comparison the effect of Olanzapine and Haloperidol on the treatment of delirium in ICU in Valiasr hospital Comparison the effect of Olanzapine and Haloperidol on the treatment of delirium in ICU in Valiasr hospital 2019-01-05 anticipated 50 Complete https://irct.ir/trial/39819 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random number table in division of groups in two groups A and B Randomization method: Simple randomization. Random unit: Individual. How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group. Allocation concealment:Numbered drug containers, 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.In order to blind the patients in the hallopridol group, the placebo tablet and we inject ampule of normal saline intramuscularly in the olanzapine group. 2-3 Delirium. Intervention 1: Intervention group 1: We inject Haloperidol 2/5 milligram (maximum 40 milligram) intramuscular injection every 6 hours. Intervention 2: Intervention group 2: We inject 2/5 to 10 milligram Olanzapine orally (maximum 20 milligram). 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 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 86 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) Delirium detection Age older than 18 years No pregnancy and breastfeeding Insensitivity to Olanzapine and Haloperidol Absence of QTC is greater than 440 milliseconds Absence of a neurological disease such as stroke, dementia, psychosis Having a urine catheter Lack of mental disorder or disability disorder pre-admission 18 years no limit Both Patients who have more than 24 hours of coma and have a structural reason for their low level of consciousness. Dissatisfaction F05 Delirium due to known physiological condition Treatment - Drugs Treatment - Drugs Intervention group 1: We inject Haloperidol 2/5 milligram (maximum 40 milligram) intramuscular injection every 6 hours. Intervention group 2: We inject 2/5 to 10 milligram Olanzapine orally (maximum 20 milligram). Sedation. Timepoint: Every 8 hours. Method of measurement: Richmond agitation and sedation scale. Illness severity. Timepoint: In first and third day after the intervention. Method of measurement: APACHE II score. Arak University of Medical Sciences Approved 2018-12-30 Ethics committee Arak University Of Medical Sciences Vice chancellor for research, Payambar Azam Complex, Basij Squre, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)