Effect of memantime in post operative cognition disorder (POCD), after coronary artery bypass graft (CABG).
bypass graft (CABG), based on wechsler score
The aim of this clinical trial is to evaluate the effect of Memantin in post-operative cognition disorders. 160 patients of ages 45-75 years with no previous neurologic dysfunction, who are candidates for CABG, will be randomized to be in control or test group. Patients in test group will receive 5 mg Memantin twice daily from the time of admission to 3 months. The cognition status will be assessed by the Wechsler memory test in both control and test group at the time of admission, after CABG, and when any of individual returns to follow up 3 months after discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303168698N12
Registration date:2013-06-17, 1392/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-17, 1392/03/27
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sience
Expected recruitment start date
2013-05-27, 1392/03/06
Expected recruitment end date
2014-10-05, 1393/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of memantime in post operative cognition disorder (POCD), after coronary artery bypass graft (CABG).
bypass graft (CABG), based on wechsler score
Public title
Effect of memantime in post operative cognition disorder (POCD), after coronary
artery bypass graft (CABG).
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who undergone CABG surgery؛ Having Wechsler score whithin normal range؛ Having Literacy
Exclusion criteria:
Patients younger than 45 years and older than 75 years؛ History of neurologic disorder
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center
Street address
Tehran Heart Center, Kargar Shomali Ave.
City
Tehran
Postal code
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
754
Health conditions studied
1
Description of health condition studied
Patients who are candidate for coronary artery bypass surgery
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Cognition Disorder
Timepoint
First day of admision, After CABG, 3 mounth after discharg
Method of measurement
wechsler Score
Secondary outcomes
1
Description
Anxiety
Timepoint
First day of admision, At the time of discharge, 3month after discharg
Method of measurement
Hemilton
Intervention groups
1
Description
In test group: Tab memantin 5 mg twice daily for 3 mounths and assessed with a wechsler Cognition test.
Category
Treatment - Drugs
2
Description
In control group: Just assessed with a wechsler Cognition test.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Saba Ghaffary Eyrdmousa
Street address
Tehran Heart Center, Kargar Shomali Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Saeedi
Street address
School of Pharmacy, Tehran University of Medical Sciences, 16 Azar St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Azita Haj Hossein Talasaz
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Pharmacy, 16 Azar St.
City
Tehran
Postal code
Phone
+98 912 377 8707
Fax
Email
atalasaz@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Full name of responsible person
Azita Haj Hossein Talasaz, Padideh Ghaeli
Position
Assistant Professor, Professor
Other areas of specialty/work
Street address
Tehran Heart Center, Kargar Shomali St.
City
Tehran
Postal code
Phone
00982188029600 - 00982166954709
Fax
Email
atalasaz@razi.tums.ac.ir, mmppg@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saba Ghaffary Eyrdmousa
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Pharmacotherapy Department, School of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
saba_gh_64@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)