Aim of this study is comparison the Effect of Quetiapine and Haloperidol on the Treatment of delirium in ICU in Valiasr hospital.
Design
This study is clinical trial and double blind. patients with delirium referred ICU in Valiasr hospital enter this study . 60 patients enter this study. We divide patients in 2 group randomly.
Settings and conduct
This study is clinical trial and double blind. patients with delirium referred ICU in Valiasr hospital enter this study . 60 patients enter this study. We divide patients in 2 group randomly.This study is double blind.Outcome elevator and participant are blind (double blind).Outcome elevator and participant don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Delirium detection, more than 18 years
exclusion criteria: Dissatisfaction
Intervention groups
We inject 2.5 milligram in day Haloperidol in first group. We inject 25 milligram Quetiapine twice in day in second group.
Main outcome variables
sedation, illness severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180911040998N1
Registration date:2018-10-31, 1397/08/09
Registration timing:registered_while_recruiting
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Alireza Toghra
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
ar.toghra@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Quetiapine and Haloperidol on the Treatment of delirium in ICU
Public title
Comparison the Effect of Quetiapine and Haloperidol on the Treatment of delirium in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Delirium detection
more than 18 years
Exclusion criteria:
Dissatisfaction
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Outcome elevator and participant are blind (double blind).Outcome elevator and participant don't aware from grouping.The participants are not aware of group name that they are.
The outcome evaluator don't knows the groups as A and B and is unaware of type of treatment in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.ARAKMU.REC.1396.286
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
sedation
Timepoint
Every day to end of intervention
Method of measurement
Richmond agitation and sedation scale
2
Description
Illness severity
Timepoint
1, 3, 7 and 10 day after start of intervention
Method of measurement
APACHE II
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: We inject 2.5 milligram in day Haloperidol in first group.
Category
Treatment - Drugs
2
Description
Intervention group2: We inject 25 milligram Quetiapine twice in day in second group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmudie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
b.mahmudie@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
m.arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmudie
Position
Assisstante professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street