The aim of this randomized double-blind clinical trial is to comparison of cardioplegic solutions which contain lidocaine or procaine hydrochloride in cognitive function after CABG procedure in Mazandaran Heart Center. A total of 110 patients, meeting eligibility criteria, are randomly allocated into two equal groups. Inclusion criterias are informed written consent; Elective CABG surgery; Age between 20 and 70 years; Use of the cardiopulmonary pump during surgery.
Exclusion criterias are history of symptomatic cerebrovascular disease; Alcohol use (> 50 cc /day); History of psychiatric illness (any clinical diagnosis requiring therapy); History of drug abuse (any illicit drug abuse in the past 3 months); Hepatic insufficiency (liver function tests > 1.5 times of the normal upper limit); Sever pulmonary insufficiency (requiring home oxygen therapy); Renal failure (baseline serum creatinine > 2mg/dl); Lack of cooperation in response to cognitive test; together with other cardiac surgery (valvular surgery); History of previous cardiac surgery; Ejection fraction < 35%; history of sensitivity to lidocaine or procaine hydrochloride.
After connecting the patients to cardiopulmonary pump, for inducing of cardiac arrest, in the control group cardioplegic solution with 5 mg/kg procaine hydrochloride and in the intervention group cardioplegic solution with 2 mg/kg lidocaine are used. Cognitive function test will be done by The Folstein Mini Mental exam the day before, 10 days and 2 months after operation. Assessments perform individually by an experienced psychometrician who was blinded to treatment group. Also, just before operation, 10 and 60 minutes after connecting the patients to cardiopulmonary pump, 5cc arterial blood was taken to determine blood levels of lidocaine.
General information
Acronym
CABG= Coronary Artery Bypass Graft
IRCT registration information
IRCT registration number:IRCT201104224365N8
Registration date:2011-06-28, 1390/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-28, 1390/04/07
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2011-06-15, 1390/03/25
Expected recruitment end date
2011-08-16, 1390/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cardioplegic solutions which contain lidocaine or procaine hydrochloride in cognitive function after CABG surgery
Public title
Cognitive deficit in first time CABG patients receiving Lidocaine versus procaine hydrochloride as an additive to the cardioplegia solution
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Informed written consent; Elective CABG surgery; Age between 20 and 70 years; Use of the cardiopulmonary pump during surgery.
Exclusion criteria: History of symptomatic cerebrovascular disease; Alcohol use (> 50 cc /day); History of psychiatric illness (any clinical diagnosis requiring therapy); History of drug abuse (any illicit drug abuse in the past 3 months); Hepatic insufficiency (liver function tests > 1.5 times of the normal upper limit); Sever pulmonary insufficiency (requiring home oxygen therapy); Renal failure (baseline serum creatinine > 2mg/dl); Lack of cooperation in response to cognitive test; together with other cardiac surgery (valvular surgery); History of previous cardiac surgery; Ejection fraction < 35%; history of sensitivity to lidocaine or procaine hydrochloride.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Ethic committee of Mazandaran University of Medical Sciences
Street address
Moallem Square, Mazandaran University of Medical Sciences
City
Sari
Postal code
46175866
Approval date
2011-06-15, 1390/03/25
Ethics committee reference number
90-64
Health conditions studied
1
Description of health condition studied
Cognitive function after CABG surgery
ICD-10 code
F54
ICD-10 code description
Psychological and behavioural factors associated with disorders or diseases classified elsewhere
Primary outcomes
1
Description
Cognitive function
Timepoint
The day before, 10 days and 2 month after operation
Method of measurement
Folstein Neurocognitive Test
Secondary outcomes
1
Description
Cardiac Dysrrhythmia
Timepoint
Before trial, during the operation and three days later
Method of measurement
Cardiac monitoring
2
Description
Serum lidocaine level
Timepoint
10 min before CPB, 10 and 60 min after CPB
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group receive lidocaine 2 mg/kg in cardioplegia solution
Category
Treatment - Drugs
2
Description
Control group receive procaine hydrochloride 5 mg/kg in cardioplegia solution
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart center
Full name of responsible person
Afshin Gholipour Baradari
Street address
Artesh Blvd
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Moallem Square, Mazandaran university of medical sciences, Sari, Iran
City
Sari
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 of Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari MD
Position
CCMF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Moallem Square, Mazandaran University of Medical Sciences