Evaluayion effect of Olanzapine and Haloperidol on the treatment of delirium in ICU in Valiasr hospital
Design
This study is clinical trial and double blind.50 patients with delirium in ICU in Valiasr Hospital in Arak will inter this study.We will divide patients in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
This study is clinical trial and double blind.50 patients with delirium in ICU in Valiasr Hospital in Arak will inter this study.Outcome assessor and analyzer don't aware from grouping.We record sedation and illness severity.
Participants/Inclusion and exclusion criteria
Inclusion criteria: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
Exclusion criteria:Patients who have more than 24 hours of coma and have a structural reason for their low level of consciousness, dissatisfaction
Intervention groups
Intervention group 1: We inject Haloperidol 2/5 milligram (maximum 40 milligram) intramuscular injection every 6 hours.
Intervention group2: We inject 2/5 to 10 milligram Olanzapine orally (maximum 20 milligram).
Main outcome variables
sedation, illness severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N114
Registration date:2019-07-03, 1398/04/12
Registration timing:registered_while_recruiting
Last update:2019-07-03, 1398/04/12
Update count:0
Registration date
2019-07-03, 1398/04/12
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Olanzapine and Haloperidol on the treatment of delirium in ICU in Valiasr hospital
Public title
Comparison the effect of Olanzapine and Haloperidol on the treatment of delirium in ICU in Valiasr hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Patients who have more than 24 hours of coma and have a structural reason for their low level of consciousness.
Dissatisfaction
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences