The current study as a random double blind clinical trial will be done. The aim of this study is to investigate the protective effect of dexmedetomidine on myocardial injury in on-pump coronary artery bypass grafting (CABG) surgery.110 patients undergoing elective coronary artery bypass surgery will be randomly divided into two groups of dexmedetomidine and control.Inclusion criteria: Isolated and elective CABG surgery; Age 35 to 65 years old; 3 or 4 coronary artery stenosis; Exclusion criteria: Patients with bradycardy based on preoperative diagnosis.The dexmedetomidine group will receive an infusion of dexmedetomidine (0.3 - 0.5 µ/kg/h) for 24 hours. In Contrl group: An infusion of normal salin (0.3 - 0.5 µ/kg/h) after induction for 24 hours.Anesthesia and surgery will be carried out according to the standard protocol. One surgeon will perform all surgeries.Troponin I, CK-MB and Serum Cortisol level will be measured at 5 point times. Before anesthesia (T0), 6 hrs post-surgery (T1), 12 hrs post-surgery (T2), 24 hrs post-surgery (T3), 48 hrs post-surgery (T4).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071113456N6
Registration date:2016-08-02, 1395/05/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-02, 1395/05/12
Registrant information
Name
Abbas Sedighinejad
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 132 5712
Email address
a_sedighinejad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Guilan University of Medical Sciences
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the protective effect of dexmedetomidine on myocardial injury in on-pump coronary artery bypass grafting (CABG) surgery
Public title
Cardio protective effect of dexmedetomidine in CABG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Isolated and elective CABG surgery; Age 35 to 65 years old; 3 or 4 coronary artery stenosis; EF>45%;Normal sinus rhythm and normal heart rate; myocardial enzymes troponin and CK-MB levels before surgery in normal range; Exclusion criteria:Heart Rate<50; SBP<90 mmHg;Thyroid dysfunction
uncontrolled diabetes; History of corticosteroid therapy; addiction
Age
From 35 years old to 65 years old
Gender
Both
Phase
2-3
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
Randomized in blocks quaternary
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193833697
Approval date
2016-05-10, 1395/02/21
Ethics committee reference number
IR.GUMS.REC.1395.46
Health conditions studied
1
Description of health condition studied
myocardial injury
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Levels of CK-MB
Timepoint
Before anesthesia(T0); 6 hr post surgery(T1); 12 hrs post surgery (T2) ; 24 hrs post surgery (T3) ;48 hrs post surgery (T4)
Method of measurement
Immunoassay
2
Description
Serum Cortisol level
Timepoint
Before anesthesia(T0); 6 hr post surgery(T1); 12 hrs post surgery (T2) ; 24 hrs post surgery (T3) ;48 hrs post surgery (T4)
Method of measurement
Immunoassay
Secondary outcomes
1
Description
Serum levels of Troponin I
Timepoint
Before anesthesia(T0); 6 hr post surgery(T1); 12 hrs post surgery (T2) ; 24 hrs post surgery (T3) ;48 hrs post surgery (T4)
Method of measurement
immunoassay
Intervention groups
1
Description
Intervention group: An infusion of dexmedetomidine (0.3 - 0.5 µ/kg/h) after induction for 24 hours
Category
Treatment - Drugs
2
Description
Contrl group: An infusion of normal salin((0.3 - 0.5 µ/kg/h) after induction for 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Abbas Sedighinejad
Street address
Hashmat Square
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Dr. Tabari
Street address
Shahid Beheshti Freeway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Abbas Sedighinejad
Position
Anesthesiologist/Associated Proffesor
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3336 8534
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Abbas Sedighinejad
Position
Anesthesiologist/Associated Proffessor
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4193955599
Phone
+98 13 3336 8534
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3336 8534
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)