Comparison of the effect of low-dose amiodarone alone and its combination with magnesium in the control of atrial fibrillation after coronary artery bypass graft
Comparison of the effect of low-dose Amiodarone alone and its combination with magnesium in the control of atrial fibrillation after coronary artery bypass graft
Design
The study will be double blind and clinical trial.208 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients candidate for coronary artery bypass graft surgery in Amiralmomenin Hospital in Arak are divided into 2 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients are candidates for coronary artery bypass graft surgery, their surgery is ON Pump ,absence of emergency coronary artery bypass graft surgery, lack of valve repair and replacement surgery, insensitivity to Amiodarone and Magnesium
Exclusion criteria:Patients who suffer from cardio-respiratory arrest during surgery and die during surgery, patients who go to the cardiopulmonary pump more than once for any reason.
Intervention groups
Intervention group 1: 300 milligram of Amiodarone is placed on the syringe pump, which is infused for the patient in 20 minutes, and 2 grams of magnesium sulfate will be slowly injected for the patients.
Intervention group 2: We will provide only 300 milligram of Amiodarone in the form of infusion for patients.
Main outcome variables
Duration of hospitalization in the intensive care unit, incidence of atrial fibrillation, mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N169
Registration date:2021-11-06, 1400/08/15
Registration timing:prospective
Last update:2021-11-06, 1400/08/15
Update count:0
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low-dose amiodarone alone and its combination with magnesium in the control of atrial fibrillation after coronary artery bypass graft
Public title
Comparison of the effect of low-dose amiodarone alone and its combination with magnesium in the control of atrial fibrillation after coronary artery bypass graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients are candidates for coronary artery bypass graft surgery
Their surgery is ON Pump
Absence of emergency coronary artery bypass graft surgery
Lack of valve repair and replacement surgery
Insensitivity to Amiodarone and Magnesium
Exclusion criteria:
Patients who suffer from cardio-respiratory arrest during surgery and die during surgery.
Patients who go to the cardiopulmonary pump more than once for any reason.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
208
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 2 and 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double-blind study. Analysts, evaluators, and participants are unaware of the consequences of grouping.The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern, and the patients are not aware of their group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-08-29, 1400/06/07
Ethics committee reference number
IR.ARAKMU.REC.1400.134
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft
ICD-10 code
I25.709
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris
Primary outcomes
1
Description
Duration of hospitalization in the intensive care unit
Timepoint
In duration study
Method of measurement
Patient file
2
Description
Incidence of atrial fibrillation
Timepoint
From the beginning of the intervention until 72 hours after the operation
Method of measurement
Physical examination
3
Description
Mortality rate
Timepoint
During the study
Method of measurement
Patient file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 300 milligram of Amiodarone is placed on the syringe pump, which is infused for the patient in 20 minutes, and 2 grams of magnesium sulfate will be slowly injected for the patients.
Category
Treatment - Drugs
2
Description
Intervention group 2: We will provide only 300 milligram of Amiodarone in the form of infusion for patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Amiralmomenin hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali-Vice President for Research and Technology
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Rostami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Amiralmomenin Hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street