The purpose of this study was to evaluate the effect of remifentanil preconditioning on heart during on-pump coronary artery bypass grafting (CABG). This study is a prospective randomized clinical trial on 54 patients scheduled for elective on pump CABG surgery. The patients were randomized to receive Remifentanil or normal saline. Serial samples for measurement of cardiac troponin I (cTnI) were taken at the baseline and 2, 6, 12, and 24 hours after cross–clamp release. After operation the inotrop use in ICU, lengths of ICU and hospital stay were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904124297N1
Registration date:2010-08-23, 1389/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-23, 1389/06/01
Registrant information
Name
Mohammad Javad Esmaili
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7636
Email address
esmaillim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2010-10-22, 1389/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preconditioning effect of Remifentanil on myocardium in patients undergoing on-pump coronary artery bypass graft surgery
Public title
Remifentanil preconditioning in patient undergoing CABG surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing CABG, age <75 years, ejection criteria >30%
Exclusion criteria: Any other surgeries (valve replacement), off pump patients, -MI at 2 wks preior to the study, cardiogenic shock, cardiac arrest, intra aortic balloon pump, ejection fraction <30%, TU score<9, CHF, LBBB, AV block, uncontrolled HTN
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street, shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2010-06-27, 1389/04/06
Ethics committee reference number
irct-89-5110
Health conditions studied
1
Description of health condition studied
Other functional disturbances following cardiac surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Troponin I
Timepoint
0, 2, 6, 12, 24 hours after induction
Method of measurement
labaratory
Secondary outcomes
1
Description
Hospital stay
Timepoint
During admission
Method of measurement
in days
2
Description
Inotrop use after operation
Timepoint
At admision time in ICU and hospital
Method of measurement
Inotrop use
3
Description
ICU stay
Timepoint
Duration admission
Method of measurement
in days
Intervention groups
1
Description
Intervention group: after monitoring with 5 lids ECG and pulse oximetery and noninvasive blood persior iv line was inserted, then after infusion of midazolam .02mg/kg and lidocain .5% subcutaneous arterial line was inserted with 20 gauge catheter then anesthesia induced by: midazolam , .05-.15mg/kg; fentanil, 5-10 mic/kg; propofol, .5-1.5mg/kg; pavlon.08-.15mg/kg; morphin .1-.5mg/kg. Then anesthesia was maintained with propofol, 50-150mg/kg. First, 1mcg/kg remifentanil was administered then .5 mcg/kg/min was infused for 30 minutes after induction and before sternotomy.
Category
Treatment - Drugs
2
Description
Control group: after monitoring with 5 lids ECG and pulse oximetery and noninvasive blood persior iv line was inserted, then after infusion of midazolam .02mg/kg and lidocain .5% subcutaneous arterial line was inserted with 20 gauge catheter then anesthesia induced by: midazolam , .05-.15mg/kg; fentanil, 5-10 mic/kg; propofol, .5-1.5mg/kg; pavlon.08-.15mg/kg; morphin .1-.5mg/kg. Then anesthesia was maintained with propofol, 50-150mg/kg. Normal saline was administered instead of remifentanil.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Dr Mohamad Javad Esmailli fellowship of cardiac anesthesia
Street address
Anesthesia ward, Faghihi Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Of Medical sciens
Full name of responsible person
Dr Mohamad Hosain Dabagh Manesh
Street address
ZAND street-SHIRAZ
City
SHIRAZE
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?