Comparison of prophylactic effect of amiodarone and amiodarone with vitamin c on post CABG atrial fibrillation
Design
This study is clinical trials and double blind.84 patients with Coronary Artery Bypass Graft Referring to Amiralmomenin Hospital in Arak.
Settings and conduct
This study is clinical trials and double blind.84 patients with Coronary Artery Bypass Graft Referring to Amiralmomenin Hospital in Arak.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with elective CABG; ASA class 2 and 3; Insensitivity to Amiodarone; performing surgery by a surgeon; duration of the surgery is 4 to 6 hours; all patients have normal creatinine
Exclusion criteria: going on a cardio-pulmonary pump for 2 times during operation; all patients who die during surgery; Increase the duration of the operation for more than 6 hours; cardiomegaly and CHF; Cardiomyopathy
History of cardiac arrest and CPR before surgery
Intervention groups
We inject 300 milligram Amiodarine bolus in 10-20 minute in first group after arterline.
We inject 150 milligram Amiodarine and 2 gram vitamin C in second group after arterline.
Main outcome variables
Comparison of prophylactic effect of amiodarone and amiodarone with vitamin c on post CABG atrial fibrillation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N66
Registration date:2018-02-08, 1396/11/19
Registration timing:registered_while_recruiting
Last update:2018-02-08, 1396/11/19
Update count:0
Registration date
2018-02-08, 1396/11/19
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
2017-11-11, 1396/08/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of prophylactic effect of amiodarone and amiodarone with vitamin c on post CABG atrial fibrillation
Public title
Comparision of prophylactic effect of amiodarone and amiodarone with vitamin c on post CABG atrial fibrillation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with elective CABG
ASA class 2 and 3
Insensitivity to Amiodarone
Performing surgery by a surgeon
Duration of the surgery is 4 to 6 hours
All patients have normal creatinine
Exclusion criteria:
Going on a cardio-pulmonary pump for 2 times during operation
All patients who die during surgery
Increase the duration of the operation for more than 6 hours
Cardiomegaly and CHF
Cardiomyopathy
History of cardiac arrest and CPR before surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received. Participant and Analyzer are blind (double blind).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences