Comparison between Intravenous Xylocaine, Mg sulfate and Amiodarone in the Prevention of Cardiac Arrhythmias after Aortic Declamping in Coronary Artery Bypass Surgery
Objective: To compare the effects of lidocaine, Amiodarone intravenous magnesium sulfate in preventing ventricular arrhythmia after aortic cross-declamping of in coronary artery bypass surgery.
Study design: randomized, single-blind clinical trial.
Inclusion criteria: patients undergoing elective surgery for coronary artery bypass surgery.
Exclusion criteria: history of using antiarrhythmic drugs; heart block (RBBB-LBBB-LAHB-LPHB) or pacemakers.
Two hundred patients undergoing elective surgery for coronary artery bypass surgery divided into four groups: the first group received placebo, second group received 1.5 mg / kg lidocaine, third group received 2 mg of magnesium sulfate and group IV received Amiodarone 150 mg intravenous immediately before aortic cross declamping.
The incidence of arrhythmias is observed in this period among the four groups.
Until completely disconnecting the patient from the pump other measures to treat arrhythmias such shocks should be recorded.
Drugs and placebo will be injected by third person when patient is rewarming (warm the patient up to 37 °) exactly 5 minutes before aortic cross-declamping.
Arrhythmia in aortic cross-declamping, drugs, inotropes, shock, balloon pumps will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040519470N55
Registration date:2017-06-22, 1396/04/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-22, 1396/04/01
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Gerash University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Intravenous Xylocaine, Mg sulfate and Amiodarone in the Prevention of Cardiac Arrhythmias after Aortic Declamping in Coronary Artery Bypass Surgery
Public title
Comparison between Intravenous Xylocaine, Mg sulfate and Amiodarone in the Prevention of Cardiac Arrhythmias after Aortic Declamping in Coronary Artery Bypass Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing elective surgery for coronary artery bypass surgery.
Exclusion criteria: history of using antiarrhythmic drugs; heart block (RBBB-LBBB-LAHB-LPHB) or pacemakers.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gerash University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Gerash
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.GERUMS.REC.1395.1.16
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
arrhythmias
Timepoint
after aortic cross declamping perioperatively
Method of measurement
EKG monitoring
2
Description
Total inotropes consumption
Timepoint
Perioperatively
Method of measurement
Observasion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: patients received 1.5 mg / kg lidocaine, intravenous immediately before declamping.
Category
Treatment - Drugs
2
Description
Intervention group 2: patients received 2 mg of magnesium sulfate intravenous immediately before declamping.
Category
Treatment - Drugs
3
Description
Intervention group 3: patients received 150 mg Amiodarone intravenous immediately before declamping.
Category
Treatment - Drugs
4
Description
Control group: patients received 5 CC normal saline immediately before declamping.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahi Faghihi Hospital
Full name of responsible person
Jalal Saeem
Street address
Shahid Faghihi Hospital, Zand Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Jalal Saeem
Street address
Vice chancellor of research ,Emam Hosein boulevard , Danshjoo street Gerash University of Medical Sciences
City
Gerash
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, 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
Elahe Allahyari
Position
Fellow ship of cardoanesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
allahyarye@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gerash Universiy of Medical Sciences
Full name of responsible person
Jalal Saeem
Position
Cardio-anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Gerash
Postal code
Phone
+98 71 3647 4270
Fax
Email
saemj@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, 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)