This study will be done as a random double blind clinical trial .The aim of this study is to investigate the effect of dexmedetomidine on postoperative atrial fibrillation in patients under coronary artery bypass graft surgery. In this study, 110 patients undergoing elective coronary artery bypass surgery will be randomly divided in two groups of dexmedetomidine and placebo. Randomization will be performed through block randomization method. Inclusion criteria: elective CABG surgery; 35 to 65 year old patients; 3 or more coronary artery stenosis. Exclusion criteria: pre-operative diagnosed bradycardia. Intervention group will receive an infusion of dexmedetomidine after induction, as much as 0.3-0.5 μgr/kg per hour for 24 hours. Control group will receive infusion of normal salin after induction, as much as 0.3-0.5 μgr/kg per hour for 24 hours.
Anesthesia and surgery method will be the same according to the standard protocol in both groups. All surgeries will be performed by one surgeon.
The incidence of postoperative atrial fibrillation will be recorded by bedside monitoring and 12 lead electrocardiograms. Outcomes of interest: First time of receiving bolus morphine, total dose of morphine received during first 48 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021914359N4
Registration date:2017-03-20, 1395/12/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-20, 1395/12/30
Registrant information
Name
Vally Imantalab
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 9064
Email address
vimantalab@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Guilan University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of dexmedetomidin and placebo on postoperative atrial fibrillation control in patients undergoing coronary artery bypass graft surgery
Public title
effect of dexmedetomidin on post CABG atrial fibrillation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: elective CABG surgery; 35 to 65 year old patients; 3 or more coronary artery stenosis; EF>45%; normal sinus rhythm; normal liver and kidney function. Exclusion criteria: pre-operative diagnosed bradycardia; HR<50; pregnancy; thyroid dysfunction; uncontrolled diabetes; history of corticosteroids use; 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti highway
City
Rasht
Postal code
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
IR.GUMS.REC.1395.312
Health conditions studied
1
Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Morphin requirement
Timepoint
within 48 hours after ICU admission
Method of measurement
Visual analogue score
2
Description
onset of atrial fibrillation
Timepoint
Within 24 hours of ICU admission
Method of measurement
ECG 12 lead whenever seen arrhythmia in monitoring and 24 hours monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: An infusion of dexmedetomidine after induction, as much as 0.3-0.5 μgr/kg per hour for 24 hours
Category
Treatment - Drugs
2
Description
Control group: infusion of normal salin after induction, as much as 0.3-0.5 μgr/kg per hour for 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat hospital
Full name of responsible person
Vali Imantalab
Street address
Heshmat 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
Shadman naemati
Street address
Shahid Beheshti
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
Heshmat hospital
Full name of responsible person
Dr Vali Imantalab
Position
associate professor
Other areas of specialty/work
Street address
Heshmat square
City
Rasht
Postal code
4193833697
Phone
+98 911 131 6138
Fax
Email
arcguilan1392@gmail.com; vimantalab@gums.ac.ir
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Heshmat square
Full name of responsible person
Dr Vali Imantalab
Position
associate professor / anesthesiologist
Other areas of specialty/work
Street address
Heshmat square
City
Rasht
Postal code
4193833697
Phone
+98 911 131 6138
Fax
Email
arcguilan1392@gmail.com; vimantalab@gums.ac.ir
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Anestesiology Research Center
Full name of responsible person
Mahsa Riazi
Position
Research Expert / MA in administration
Other areas of specialty/work
Street address
Vellayat Hospital
City
Rasht
Postal code
Phone
00
Fax
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)