This double blind randomized clinical trial and single institutional study was conducted with objective of evaluation of dexamethasone effects on postoperative deliriums and complications after cardiac surgery. Inclusion criteria was candidacy for coronary baypass surgery and exclusion criteria was longer duration of cardiopulmunary bypass (more than 3 hour), age older than 80 years, Eejection fraction lower than 20%, instability of hemodynamic, history of delirium, and emergency operation. Totally, 110 eligible patients who undergone coronary arteries bypass graft was divided into 2 groups. Dexamethasone group taken 8mg dexamethasone before induction of anesthesia followed by 8mg every 8 hours for 3 day and other group received placebo in same way.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202229108N1
Registration date:2012-03-15, 1390/12/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-15, 1390/12/25
Registrant information
Name
Hamid Bigdelian
Name of organization / entity
Isfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1260 7357
Email address
bigdelian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2009-02-01, 1387/11/13
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Dexamethasone effects on Postoperative Delirium after coronary artery bypass
Public title
Effect Of Dexamethasone
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Canidateted patients for coronary baypass surgery Exclusion criteria: longer duration of cardiopulmunary bypass (more than 3 hour); age older than 80 years; EF lower than 20%; instability of hemodynamic; history of delirium; emergency operation
Age
To 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Postal code
Approval date
2008-10-25, 1387/08/04
Ethics committee reference number
123628
Health conditions studied
1
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Postoperative Delirium
Timepoint
first, 2nd, 3ed postoperative day
Method of measurement
MME questionaire
Secondary outcomes
1
Description
intensive care unit and hospital length of stay
Timepoint
after discharge
Method of measurement
hospital documents
Intervention groups
1
Description
Intravenous injection of 2cc equal with 8mg of dexamethasone before surgery, following by 2cc(8mg) of dexamethasone every 8 hour for 3 day
Category
Treatment - Drugs
2
Description
Intravenous injection of 2cc Normal saline(placebo) before surgery, following by 2cc of normal saline every 8 hour for 3 day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Heart Center
Full name of responsible person
Hamid Bigdelian
Street address
Chamran Heart Center, Salman farsi Ave
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hamid bigdelian
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Cardiac surgery, Isfahan University of Medical Sciences
Full name of responsible person
Hamid Bigdelian
Position
Assistant Professor, MD.
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave
City
isfahan
Postal code
Phone
+98 31 1260 7357
Fax
Email
Bigdelian@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Cardiac surgery, Isfahan University of Medical Sciences
Full name of responsible person
Hamid Bigdelian
Position
Assistant professor, MD.
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib Ave
City
Isfahan
Postal code
Phone
+98 31 1260 7357
Fax
Email
Bigdelian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Cardiac surgery, Isfahan University of Medical Sciences
Full name of responsible person
Hamid Bigdelian
Position
Assistant professor, MD.
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib Ave
City
Isfahan
Postal code
Phone
+98 31 1260 7357
Fax
Email
Bigdelian@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)