Objective: To evaluate the effect of Amiodarone in preventing arrhythmia in patients undergoing coronary artery bypass surgery. Study design: double-blind randomized Clinical Trial.
Inclusion criteria: Patients who completed written consent to participate in the study and candidate for CABG; patients older than 18 years.
Exclusion criteria: diabetes; hypothyroidism or hyperthyroidism Cr> 2; liver failure (increased SGOT; SGPT) and patients with chronic obstructive pulmonary diseases (except asthma; bronchitis and emphysema); AF; under 18 years of age; pregnancy and EF more than 30% are the exclusion criteria.
Intervention: 60 patients were randomly divided into the two groups; however in the study group patients received infusion of Amiodarone (3mg / kg) 10 minutes before declamping of the aorta and in the control group patients received 10cc of saline 10 minutes before declamping of the aorta.
Three minutes before aortic clamp removal; syringes containing (Amiodarone or placebo) are injected through 30 minutes; cardiac arrhythmia such as premature ventricular contractions; premature atrial contractions; PVC bigeminy and trigeminy; branch blocks; asystol; VT and VF; etc. will be recorded.
All interventions carried out with cardio-surgeon or anesthesiologist and cardiac arrhythmia will be recorded after chest tube insertion and close the sternum up to 24 hours after patient arrival to the ICU.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053014372N7
Registration date:2016-06-29, 1395/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-29, 1395/04/09
Registrant information
Name
Simin Azemati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4270
Email address
azemati@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2016-04-18, 1395/01/30
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Amiodarone on Prevention of Arrhythmias in Patients underwent Coronary Artery Bypass Graft Surgery
Public title
Evaluation of the Effect of Amiodarone on Prevention of Arrhythmias in Patients underwent Coronary Artery Bypass Graft Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients who completed written consent to participate in the study and candidate for CABG; patients older than 18 years.
Exclusion criteria: diabetes; hypothyroidism or hyperthyroidism Cr> 2; liver failure (increased SGOT; SGPT) and patients with chronic obstructive pulmonary diseases (except asthma; bronchitis and emphysema); AF; under 18 years of age; pregnancy and EF more than 30% are the exclusion criteria.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiaz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2016-02-17, 1394/11/28
Ethics committee reference number
IR.SUMS.Med.RED.1394.205
Health conditions studied
1
Description of health condition studied
coronary arthery heart disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
REPERFUSION VENTRICULAR FIBRILATION
Timepoint
30 min after declamping
Method of measurement
MONITOR OF EKG
2
Description
Arrhythmia
Timepoint
during 24 h of ICU stay
Method of measurement
MONITOR OF EKG AND EKG
Secondary outcomes
empty
Intervention groups
1
Description
in the intervention group patients received infusion of Amiodarone(HAMELN-GERMANY) (3mg / kg) 10 minutes before decamping of the aorta a
Category
Treatment - Drugs
2
Description
in the control group patients received 10cc of saline 10 minutes before decamping of the aorta
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Sima Eghdami
Street address
Namazi squer, Namazi Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences ,Zand streetl
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sima Eghdami
Position
Perfusionist
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
sims_eghdami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr SIMIN AZEMATI
Position
Cardio,Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
azematis@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz anesthesiology and critical care research center
Full name of responsible person
Farzaneh Masihi
Position
English Consultant
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Research Tower, 5 th floor, Khalili street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)