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Comparing the effect of lidocaine- magnesium sulfate with amiodarone-magnesium sulfate in preventing ventricular fibrillation after aortic cross clamp removal in coronary artery graft surgery

Protocol summary

Summary
The purpose of this study is the comparing the effect of lidocaine - magnesium sulfate with Amiodarone - Magnesium sulfate in preventing ventricular fibrillation after aortic cross clamp removal in coronary artery graft surgery Design: A prospective double blinded block randomized study Inclusion criteria: coronary artery atherosclerosis, ASA class 3-4, negative history of cardiopulmonary resuscitation, patients with a no history of intake drugs (digoxin, amiodarone, lidocaine, magnesium). Exclusion criteria: contraindication for drug intake or allergy to drugs, history of previous cardiac surgery, emergency surgery. Method: Midazolam, fentanyl, etomidate and cis-atracurium were applied for induction of anesthesia. Continuous infusion of sufentanil, midazolam and atracurium were applied for anesthesia maintenance. All patients received a 10 minutes infusion of magnesium sulfate (30mg/kg) before releasing the aortic cross clamp. Group A: A1 syringe pump (normal saline) and A2 syringe pump (100 mg lidocaine) are applied. Group B: B1 syringe pump (amiodarone 300 mg) and B2 syringe pump (normal saline) are applied. Syringes no. 1 and 2 in equal volumes of 10 cc which are applied 10 and 2 minutes before clamp removal respectively. Outcome measurements: Demographic values, ejection fraction, valvular indices, type of arrhythmia, defibrillation, drug therapy, central venous and mean arterial pressures, heart rate, blood gas indices, plasma concentrations (sodium, potassium, glucose and hematocrite), duration of cardiopulmonary pump, temperature at clamp release time, hemofilterate and cardioplegic volume.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015081723660N1
Registration date: 2017-01-20, 1395/11/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Maryam moradi shahdadi
Name of organization / entity
Hormozgan university of mediical sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3355 5601
Email address
dr.maryam.moradi@gmail.com
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of lidocaine- magnesium sulfate with amiodarone-magnesium sulfate in preventing ventricular fibrillation after aortic cross clamp removal in coronary artery graft surgery
Public title
Comparing the effect of lidocaine and magnesium sulfate combination with amiodarone and magnesium sulfate combination in preventing ventricular fibrillation heart rhythms after aortic artery occlusion clamp removal during the coronary artery graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class 3-4, atherosclerosis vessel coronary-history with no previous cardiopulmonary resuscitation, patients with no medication of digoxin-amiodarone-lidocaine-magnesium Exclusion criteria: Concurrent other cardiac surgery, emergency surgery, allergy to drugs
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy for Research, and Medical Ethics Committee of Hormozgan University of Medical Sciences
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital
City
Bandar Abbas
Postal code
7919915519
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
HUMS-REC-1394-65

Health conditions studied

1

Description of health condition studied
Ventricular fibrillation in coronary artery bypass graft operation
ICD-10 code
I49.0
ICD-10 code description
Ventricular fibrillation and flutter

Primary outcomes

1

Description
Ventricular fibrillation
Timepoint
15 minute before operation till 24 hours after operation in ICU
Method of measurement
Electrocardiography

Secondary outcomes

1

Description
Central venous pressure
Timepoint
15 minutes after anesthesia induction and 15 minutes after starting cardiopulmonary bypass
Method of measurement
Central venous pressure transducer monitor

2

Description
Mean arterial pressure
Timepoint
15 minutes after anesthesia induction and 15 minutes after starting cardiopulmonary bypass
Method of measurement
Invasive arterial blood pressure monitor

3

Description
heart rate
Timepoint
15 minutes after anesthesia induction and 15 minutes after starting cardiopulmonary bypass
Method of measurement
electrocardiography monitor

4

Description
Arterial blood gases (pH, arterial partial pressure of oxygen, arterial partial pressure of carbon dioxide, bicarbonate concentration)
Timepoint
At phases of (base line, heart arrest, patient warming, and pump separation)
Method of measurement
Arterial catheter blood sampling

5

Description
Plasma (Na-K) electrolytes
Timepoint
At phases of (base line, heart arrest, patient warming, and pump separation)
Method of measurement
Arterial catheter blood sampling

6

Description
Blood plasma glucose
Timepoint
At phases of (base line, heart arrest, patient warming, and pump separation)
Method of measurement
Arterial catheter blood sampling

7

Description
Complete blood count of plasma
Timepoint
At phases of (base line, heart arrest, patient warming, and pump separation)
Method of measurement
Arterial catheter blood sampling

Intervention groups

1

Description
All the patients received a standard monitoring, arterial and central venous catheter insertion. Premedication was applied by administering midazolam (0.05 mg/kg) with fentanyl (10 microgram/kg) and for anesthesia induction, etomidate (0.2 mg/kg), cis-atracurium (0.2 mg/kg) were administered, tracheal intubation and mechanical ventilation was established thereafter. Anesthesia was maintained by the infusion of sufentanil (0.01 microgram/kg/min), midazolam (1 mg/kg/min) and atracurium (8 microgram/kg/min). All the patients received a 30 mg/kg of sulphate magnesium through the bypass pump 10 minutes before the aortic cross clamp removal. The events recordings during anesthesia and drug administrations were performed by a qualified anesthesia technician who was not aware of the contents of the study syringes. Group A: Received the syringe pump A1 (10 cc of normal saline) 10 minutes before the opening of the aortic cross clamp and syringe pump A2 (2% lidocaine 1.5 mg/kg) 2 minutes before opening the aortic cross clamp were administered to the patients.
Category
Treatment - Drugs

2

Description
All the patients received a standard monitoring, arterial and central venous catheter insertion. Premedication was applied by administering midazolam (0.05 mg/kg) with fentanyl (10 microgram/kg) and for anesthesia induction, etomidate (0.2 mg/kg), cis-atracurium (0.2 mg/kg) were administered, tracheal intubation and mechanical ventilation was established thereafter. Anesthesia was maintained by the infusion of sufentanil (0.01 microgram/kg/min), midazolam (1 mg/kg/min) and atracurium (8 microgram/kg/min). All the patients received a 30 mg/kg of sulphate magnesium through the bypass pump 10 minutes before the aortic cross clamp removal. The events recordings during anesthesia and drug administrations were performed by a qualified anesthesia technician who was not aware of the contents of the study syringes. Group B: Received the syringe pump B1 (10 cc solution of 300 mg amiodarone and normal saline) 10 minutes before the opening of the aortic cross clamp and syringe pump B2 (5 cc of normal saline) 2 minutes before opening the aortic cross clamp were administered to the patients.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Saeid Kashani
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Abdulazim Nejatizadeh
Street address
Joomhoori Islami Blv., Deputy of Research Center, Shahid Mohammadi Hospital
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Saeid Kashani
Position
Assistant Professor of Anesthesiology and Intensive care, Fellowship of Cardiac Surgery Anesthesia
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
sdkashani@gmail.com
Web page address
http://anrc.resv.hums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical S
Full name of responsible person
Hashem Jarineshin
Position
Assistant Professor of Anesthesiology and Intensive care, Fellowship of Cardiac Surgery Anesthesia
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Assistant Professor of Anesthesiology and Intensive care, Fellowship of Cardiac Surgery Anesthesia
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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