Comparison of the effect of Alprazolam and Quetiapine on sleep of patients who complain of insomnia after coronary artery bypass graft surgery
Design
Double blinded clinical trial with control group that has two parallel group with sample size of 64 persons
Settings and conduct
Drugs were packed in groups A and B. Drugs packs were delivered to the nurses of heart surgery ward of chamran hospital in Isfahan.
Group A drugs were prescribed for patients who were entered to ward at saturday, monday and wednesday. Group B drugs were prescribed for patients who are entered to ward at sunday, tuesday and thursday. So the physician (main researcher), nurses and patients dont know the type of drugs. The executive manager and the collector of information know type of patients drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients should undergo CABG and complain of insomnia after surgery.
Exclusion criteria:
Unstable medical conditions, History of psycological disease, Dementia, Acute narrow angle glaucoma, Hypersensitivity to drug.
Intervention groups
32 patients receive half of TRANQOPINE 25mg tablet, every nights 30 minutes before sleep, from 3 days after surgery until 14 days after surgery.
32 patients receive one ALPRAZOLAM 0.5 mg tablet from abidi company, every nights 30 minutes before sleep, from 3 days after surgery untile 14 days after surgery.
Main outcome variables
Insomnia Score according to (ISI) questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160716028945N4
Registration date:2018-11-07, 1397/08/16
Registration timing:retrospective
Last update:2018-11-07, 1397/08/16
Update count:0
Registration date
2018-11-07, 1397/08/16
Registrant information
Name
Amir Mirmohammadsadeghi
Name of organization / entity
Isfahan Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3260 0961
Email address
am_sadeghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-03-18, 1396/12/27
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2018-06-19, 1397/03/29
Trial completion date
2018-06-19, 1397/03/29
Scientific title
Comparison of the effect of Quetiapine and Alprazolam on sleep in patients who complain of insomnia after CABG (coronary artery bypass graft) surgery
Public title
Comparison of the effect of Quetiapine and Alprazolam on insomnia after coronary artery bypass graft sugery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient should undergo CABG and complain of insomnia after surgery
Exclusion criteria:
Unstable medical conditions
History of psycological disease
Dementia
Acute narrow angle glaucoma
Hypersensitivity to drug
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
64
Actual sample size reached:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs were packed in groups A and B. Drugs packs were delivered to the nurses of heart surgery ward.
Group A drugs were prescribed for patients who were entered to ward at saturday, monday and wednesday.
Group B drugs were prescribed for patients who are entered to ward at sunday, tuesday and thursday.
So the physician (main researcher), nurses and patients dont know the type of drugs.
The executive manager and the collector of information know type of patients drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Science
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
IR.MUI.REC.1396.3.191
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
G47.09
ICD-10 code description
Other insomnia
Primary outcomes
1
Description
Insomnia score according to (ISI) questionnaire
Timepoint
Three days after surgery(before intervention) and fourteen days after surgery
Method of measurement
(ISI) insomnia questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 32 patients recieve half of TRANQOPINE 25mg tablet, every nights 30 minutes before sleep, from 3 days after surgery until 14 days after surgery.
Category
Treatment - Drugs
2
Description
Control group: 32 patients recieve a ALPRAZOLAM 0.5 mg tablet from abidi company, Every nights 30 minutes before sleep, From 3 days after surgery until 14 days after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Iman Nariman
Street address
Chamran Hospital, Salman Farsi st.
City
Isfahan
Province
Isfehan
Postal code
81661-73414
Phone
+98 31 3260 0961
Email
iman.narimani0@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Atar
Street address
Isfahan University of Medical Sciences, Hezar Jerib st.
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac Surgery
Street address
Chamran Hospital, Salman Farsi st.
City
Isfahan
Province
Isfehan
Postal code
81661-73414
Phone
+98 31 3260 0961
Fax
Email
am_sadeghi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac Surgery
Street address
Chamran Hospital, Salman Farsi st.
City
Isfahan
Province
Isfehan
Postal code
81661-73414
Phone
+98 31 3260 0961
Email
am_sadeghi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac Surgery
Street address
Chamran Hospital, Salman Farsi st.
City
Isfahan
Province
Isfehan
Postal code
81661-73414
Phone
+98 31 3260 0961
Email
am_sadeghi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of secondary data analyze
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available