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Comparison the effect of propofol and N-acetylcysteine on CRP and inflammatory markers after coronary bypass surgery

Protocol summary

Summary
The purpose of this study is comparison between antioxidant effects of propofol and N acetylcysteine on CRP and inflammatory markers after coronary artery bypass surgery. This study is designed as a randomized, prospective, interventional and single blind clinical trial .The study population all the patients who are candidate for coronary artery bypass surgery. Inclusion criteria consist of : Elective coronary artery bypass surgery. Exclusion criteria consist of : Off pump coronary artery bypass surgery; Severe left ventricular dysfunction, Emergency coronary artery bypass surgery; Re exploration surgery. In this study, 30 patients are selected and 15 patients in one groups are considered. One group of patients is received propofol by the dose of 100 microgram /kg/minute perioperative with sufentanil , midazolam and cis atracurium. Another group of the patients is received N acetylcysteine by the dose of 600 mg last night of surgery and this group is not received propofol in anesthesia. All patients monitored with arterial line before induction of anesthesia. Blood samples for cytokines will be drawn after induction of anesthesia , 15 minute post bypass, 3 hours post bypass and 24 hours after bypass. All patients monitored with invasive blood pressure monitoring with arterial line, central venous pressure and electrocardiography monitoring.CRP is checked last night of surgery, 4 hours and 24 hours after surgery. Hemodynamic data will be collected included systolic blood pressure, diastolic blood pressure, mean arterial blood pressure and heart rate after induction of anesthesia, 15, 30 minutes post bypass and 1,3 hours post bypass.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102035751N1
Registration date: 2012-07-05, 1391/04/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Abdolrasoul Anvaripour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1252 6801
Email address
anvari@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2012-06-09, 1391/03/20
Expected recruitment end date
2012-08-10, 1391/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of propofol and N-acetylcysteine on CRP and inflammatory markers after coronary bypass surgery
Public title
Antioxidants used in anesthesia in coronary bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
The study population of patients are 45 -75 years old candidates for coronary artery bypass surgery. Exclusion criteria consist of : Emergency coronary bypass surgery; Chronic renal failure; Chronic corticosteroid therapy; Re exploration surgery; Chronic inflammatory disease and autoimmune disease; Severe left ventricular failure(EF less than 35%); Liver disease; Infectious disease after surgery
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bahmani,pardis site of Bushehr University of Medical Sciences
City
Bushehr
Postal code
Approval date
2012-03-06, 1390/12/16
Ethics committee reference number
32949

Health conditions studied

1

Description of health condition studied
coronay artery disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
CRP
Timepoint
Last night before surgery- 4 and 24 hours after surgery
Method of measurement
arterial blood

2

Description
cytokines
Timepoint
after induction- 15 min, 3 and 24 hour after bypass surgery-
Method of measurement
arterial line

Secondary outcomes

1

Description
sysyolic blood pressure
Timepoint
pre induction of anesthesia- 15,30, 60 minute after bypass- in icu admit
Method of measurement
Arterial line

2

Description
diastolic blood pressure
Timepoint
preinduction- 15,30,60 minute post anesthesia- icu admit
Method of measurement
arterial line

3

Description
mean arterial pressure
Timepoint
preinduction- 15,30,60 minutes after bypass-icu admit
Method of measurement
arterial line

4

Description
heart rate
Timepoint
preinduction of anesthesia- 15,30,60 minutes after bypass- icu admit
Method of measurement
arterial line

Intervention groups

1

Description
N acetyl cyctein 600 mg orally last night of operation
Category
Treatment - Drugs

2

Description
propofol infusion during anesthesia and operation( 50-100 mic/kg/min)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bentolhoda Hospital- Open Heart Operation Room
Full name of responsible person
Abdolrasoul Anvaripour
Street address
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Street address
Bushehr University of Medical Sciences
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Bentolhoda hospital , Moalem Street
City
Bushehr
Postal code
Phone
+98 77 1252 6801
Fax
Email
a.anvari.p@hotmail.com anvari@bpums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Bentolhoda Hospital, Moalem Street
City
Bushehr
Postal code
Phone
+98 77 1252 6801
Fax
Email
a.anvari.p@hotmail.comanvari@bpums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Abdolrasoul Anvaripour
Position
Assistant Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 77 1252 6801
Fax
Email
Web page address

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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