Comparison of using Lidocaine versus Amiodarone for the prevention of Tachy ventricular arrhythmias after removal of Aorta cross clamp during valvular heart surgery
Comparison of Amiodarone and Lidocaine use in preventing the occurrence of ventricular tachyarrhythmias after aortic clamp removal during cardiac valve surgery
Design
Sample size: In this study, 60 patients will be randomly divided into two groups of 30 patients. Randomization will be done using blocks of size 4. This study is a single-blind clinical trial with parallel groups.
Settings and conduct
Patients Candidate for Cardiac Valve Surgery at Shahid Rajaei Pharmacy Center will receive Antiarrhythmic Drugs in Two Groups During Bypass and 5 Minutes Before Cross Clamp Opening.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient satisfaction to participate in the study; Patients candidate for open heart valve surgery; Patients over 18 years of age; normal liver enzyme levels; serum creatinine levels less than 2 mg/dl.
Non-inclusion criteria: Ejection fraction less than 30%; Carotid artery stenosis greater than 50%; previous cardiac surgery; Contraindication or severe hypersensitivity to amiodarone; lidocaine and magnesium sulfate.
Intervention groups
Intervention group 1: Lidocaine plus Magnesium Sulfate; Lidocaine 2 mg / kg plus Magnesium Sulfate 30 mg/kg and normal saline will be administered up to a total volume of 25 ml using infusion pump 5 minutes before the cross-clamp is opened.
Intervention group 2: 300 mg Amiodarone plus Magnesium Sulfate 30 mg/kg and normal saline up to a total volume of 25 ml will be administered by infusion pump 5 minutes before the cross-clamp is opened.
Main outcome variables
Occurrence ventricular tachyarrhythmias
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190901044663N1
Registration date:2020-07-08, 1399/04/18
Registration timing:retrospective
Last update:2020-07-08, 1399/04/18
Update count:0
Registration date
2020-07-08, 1399/04/18
Registrant information
Name
Fateme Hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3678 1654
Email address
hessari.fatteme@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
2019-08-21, 1398/05/30
Actual recruitment end date
2019-11-11, 1398/08/20
Trial completion date
2019-11-11, 1398/08/20
Scientific title
Comparison of using Lidocaine versus Amiodarone for the prevention of Tachy ventricular arrhythmias after removal of Aorta cross clamp during valvular heart surgery
Public title
Comparison of using Lidocaine versus Amiodarone for the prevention of tachy ventricular arrhythmias
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to participate in the study
18 years of age or older
No previous cardiac surgery
No contraindication or severe allergy to amiodarone, Lidocaine and Magnesium Sulfate
Normal serum levels of liver enzymes
Serum creatinine levels are less than 2 mg / dL.
Exclusion criteria:
Transient cerebral ischemia or stroke
Uncontrolled diabetes mellitus during study
Carotid artery stenosis over 50%
Uncontrolled hypertension
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a block randomization method is used. Randomization unit is individual and the tool used to randomize is the closed envelope. Inside each envelope is the English letter A or B. Patients fall into the Amiodaron or Lidocaine group according to the word that came out of the envelop.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant is unaware of the prescribed medication due to general anesthesia, and the data analyst, safety committee, and data monitor also do not have access to the checklist.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Rajaie Cardiovascular Medical and Research Center
Street address
Beside Mellat park; Niayesh Intersection; Valiasr street; Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2019-11-17, 1398/08/26
Ethics committee reference number
IR.RHC.REC.1398.37
Health conditions studied
1
Description of health condition studied
Ventricular tachycardia
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Ventricular tachycardia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Occurrence of ventricular tachyarrhythmias
Timepoint
During the bypass and 5 minutes before the cross-clamp opening
Method of measurement
Electrocardiograph
Secondary outcomes
1
Description
Ejection Fraction
Timepoint
24 hours after intervention
Method of measurement
Echocardiography
Intervention groups
1
Description
Intervention group 1: Lidocaine plus Magnesium Sulfate; Lidocaine 2 mg / kg plus Magnesium Sulfate 30 mg/kg and normal saline will be administered up to a total volume of 25 ml using infusion pump 5 minutes before the cross-clamp is opened.
Category
Prevention
2
Description
Intervention group 2: 300 mg Amiodarone plus Magnesium Sulfate 30 mg/kg and normal saline up to a total volume of 25 ml will be administered by infusion pump 5 minutes before the cross-clamp is opened.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fateme Hesari
Street address
No. 19, Sadat alley, Rajaie street, Shahid Ardestani town
City
Pishva
Province
Tehran
Postal code
123456789021
Phone
+98 21 3678 1654
Email
hessari.fatteme@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fateme Hesari
Street address
No. 19, Sadat alley, Rajaie street, Shahid Ardestani town
City
pishva
Province
Tehran
Postal code
3381916131
Phone
+98 21 3678 1654
Email
hessari.fatteme@gmail.com
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rajaie Cardiovascular Medical and Research Center
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
Shahid Rajaee Cardiovascular Medical and Research Center
Full name of responsible person
Fateme Hesari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No.19, Sadat alley, Rajaie street, Shahid Ardestani town
City
Pishva
Province
Tehran
Postal code
3381916131
Phone
+98 21 3678 1654
Email
hessari.fatteme@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fateme Hesari
Position
Student Master
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 19, Sadat alley, Rajaie street, Shahid Ardestani town
City
Pishva
Province
Tehran
Postal code
3381916131
Phone
+98 21 3678 1654
Email
hessari.fatteme@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Fatteme Hessari
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 19, Sadat alley, Rajaie street, Shahid Ardestani town
City
Pishva
Province
Tehran
Postal code
3381916131
Phone
+98 21 3678 1654
Email
hessari.fatteme@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available