Comparison and evaluation of cognitive impairment and cognitive function changes in patients undergoing coronary artery bypass graft surgery after premedication with doxedmodyntidine and midazolam
Determination of cognitive impairment and cognitive function changes in patients undergoing coronary artery bypass graft surgery using post-beating-on post-treatment with doxedetomidine and midazolam
Design
42 patients who undergo general anesthesia and the coronary artery bypass graft surgery with age of 40-45 are entered in this study . On the day of operation, patients are randomly divided into two groups that case group receive Dexmedetomidine and control group receive Midazolam. This study is double-blind that researcher and patients are unaware.
Settings and conduct
This project was conducted at Mashhad University of Medical Sciences.This study is double-blind that researcher and patients are unaware.
Participants/Inclusion and exclusion criteria
Patients undergoing beating-on-pump coronary artery bypass surgery under general anesthesia in hospitals affiliated to Mashhad University of Medical Sciences
Intervention groups
Intervention group: Premedication with midazolam at a dose of 0.5-0.1 mg / kg and fentanyl at a dose of 1.0-5 μg / g for propofol for induction of anesthesia and muscle relaxant to facilitate intubation.
Control group: Dexamethadone dosage of 0.5 to 0.1 mg / kg and fentanyl with g / kg 10-5-polypropofol for induction of anesthesia and muscle relaxant are used to facilitate intubation.
Main outcome variables
Cognitive status before and after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170429033680N7
Registration date:2018-02-28, 1396/12/09
Registration timing:retrospective
Last update:2018-02-28, 1396/12/09
Update count:0
Registration date
2018-02-28, 1396/12/09
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-02, 1395/08/12
Expected recruitment end date
2018-02-27, 1396/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison and evaluation of cognitive impairment and cognitive function changes in patients undergoing coronary artery bypass graft surgery after premedication with doxedmodyntidine and midazolam
Public title
Comparison and evaluation of cognitive impairment and cognitive function changes in patients undergoing coronary artery bypass graft surgery after premedication with doxedmodyntidine and midazolam
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction
On-pump surgery
Age 40 to 65 years old
Exclusion criteria:
A cardiovascular disease and prolonged CPR
DVT history in the last 6 months
A history of advanced kidney or lung disease
Duration of surgery for more than 5 hours
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization: Randomization is done using enveloped packets
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the investigator were not aware of the type of medication
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences; International Offic Administration Center(Qoreishi Building) ; Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-11-02, 1395/08/12
Ethics committee reference number
IR.MUMS.sm.REC.1394.553
Health conditions studied
1
Description of health condition studied
coronary arteries
ICD-10 code
R41.8
ICD-10 code description
Other symptoms and signs involving cognitive functions and awareness
Primary outcomes
1
Description
Cognitive function of patients
Timepoint
before and after surgery
Method of measurement
Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
after intervation
Method of measurement
Barometer
Intervention groups
1
Description
Intervention group: premedication with midazolam 0.5 and 1 mg / kg
Category
Treatment - Drugs
2
Description
Control group: Dexmedetomidine at a dose of 1 microgram per kilogram
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahsa Rajaei
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
rajaeim931@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marjan Ardakanian
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
91388 13944
Phone
+98 51 3843 3363
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza Hospital, Square Taghiabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
rajaeim931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza Hospital, Square Taghiabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
rajaeim931@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza Hospital, Square Taghiabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
golhasanif1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Article
When the data will become available and for how long
1397
To whom data/document is available
web site
Under which criteria data/document could be used
Researchers
From where data/document is obtainable
sent an email
What processes are involved for a request to access data/document