The purpose of this study is Comparison of propofol and sevoflurane anesthesia on cerebral oxygenation in patients undergoing off-pump CABG. This study is a single blind clinical trial.. patients with liver or renal disease, neurological disease, CVA prior to ejection fraction less than 30% are excluded. Using a table of random numbers patients are devided in the two groups.in all patients general anesthesia producer is similar. For maintenance Inhaled Sevoflurane 1.5_2% in group 1 and intravenous propofol 3_5 mg.kg in group 2 is administrated. History of diabetes, smoking, drug use, blood pressure, triglycerides and cholesterol are recorded. Mean arterial blood pressure, pulse rate, rso2, cvp, Lso2 before, during and after the graft is measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307242963N15
Registration date:2013-08-13, 1392/05/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-13, 1392/05/22
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Shahid Sadoughi Medical University of Yazd
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of propofol and sevofluran on cerebral oxygenation in patients undergoing off pump coronary artery bypass grafting
Public title
effect of propofol and sevofluran on cerebral oxygenation in patients undergoing off pump coronary artery bypass grafting
Purpose
Prevention
Inclusion/Exclusion criteria
including criteria:all patients undergoing for off pump coronary artery bypass grafting.
excluding criteria: liver disease ؛ renal disease ؛ nourologic disease ؛ CVA ؛EF<30%
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
shahid sadoughi medical sciences university
Street address
bahonar square
City
yazd
Postal code
Approval date
2013-01-28, 1391/11/09
Ethics committee reference number
155847/1/17/پ
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
cerebral oxygenation
Timepoint
before, during and after of grafts
Method of measurement
INVOS
Secondary outcomes
1
Description
HR
Timepoint
befoe, during and after of grafts
Method of measurement
ECG
2
Description
MAP
Timepoint
before,during and after of grafts
Method of measurement
barometer
3
Description
CVP
Timepoint
before, during,after of grafts
Method of measurement
arterial catheter
Intervention groups
1
Description
case group:propofol 3_5 mg.kg
Category
Treatment - Drugs
2
Description
control group: sevofluran 1.5_2%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
afshar hospital
Full name of responsible person
dr habibollah hosseini
Street address
afshar hospital
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahid sadoughi medical sciences university
Full name of responsible person
dr hassan mozafari
Street address
bahonar square
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahid sadoughi medical sciences university
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
shahid sadoughi medical sciences university
Full name of responsible person
dr shekufeh behdad
Position
acossiate proffesor of anesthesiology
Other areas of specialty/work
Street address
shahid sadoughi hospital
City
yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drbehdad@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahid sadoughi medical sciences university
Full name of responsible person
dr shekufeh behdad
Position
associate proffesor of anesthesiology
Other areas of specialty/work
Street address
ashahid sadoughi hospital
City
yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drbehdad@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
shahid sadoughi medical sciences university
Full name of responsible person
dr shekofeh behdad
Position
associate proffesor of anesthesiology
Other areas of specialty/work
Street address
shahid sadoughi hospital
City
yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drbehdad@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)