Objective: Decrease inotrope uses to exit the bypass pump;
Reduce the incidence of transient cardiac ischemia after surgery;
Reduce ICU staying.
Design: Randomized single-blind clinical trial.
Setting and conduct and intervention:In all patient induction( sufentanil, cis-atracurium and etomidate) and maintenance phase( sufentanil, midazolam, cis-atracurium) of anesthesia will be considered with the same protocol. After cross-clamp of aorta in intervention group, the patient will receive oxygen (2Lit/min) and sevofluran(4%) during coronary bypass surgery. After rewarming of the patients, sevofluran will be omitted.
Inclusion criteria: All elective coronary bypass surgery in patients 40 to 80 years old.
Exclusion criteria: AV block(mobitz2); complete Heart block; LBBB;
Acute heart failure(EF<30); Reexploration after surgical complications
; MI in last 7 days ago.
Main outcome measures(variables) : The effect of sevofluran on preconditioning of heart during CABG will be evaluated with checking troponin and heart nuclear scan.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061528477N1
Registration date:2016-08-02, 1395/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-02, 1395/05/12
Registrant information
Name
Sina Ofoghie Rezaei
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 3930
Email address
s.ofoghirezaei@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Boushehr 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
The effect of preconditioning of sevofluran in coronary artery bypass surgery
Public title
The effect of preconditioning of sevofluran in cardiac ischemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All elective coronary bypass surgery in patients 40 to 80 years old.
Exclusion criteria: AV block(mobitz2); complete Heart block; LBBB;
Acute heart failure(EF<30); Reexploration after surgical complications
; MI in last 7 days ago.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
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
sampling: simple randomize
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Boushehr Medical Scinces University
Street address
Boushehr Medical Scinces University,Sangi,Boushehr
City
Boushehr
Postal code
Approval date
2016-05-16, 1395/02/27
Ethics committee reference number
IR.BPUMS.REC.1395.23
Health conditions studied
1
Description of health condition studied
Preconditioning of heart during coronary artery bypass surgery
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Troponin I blood level
Timepoint
At entrance to ICU and after 4,8,24,48 hours from coronary bypass surgery
Method of measurement
μg ⁄ l0.01 SI unit
2
Description
Electrocardiography
Timepoint
ECG changes at entrance to ICU and daily up to 4 days.
Method of measurement
Electrocardiography device
3
Description
Nuclear heart scan
Timepoint
3 nuclear heart scan befor CABG and 1 and 6 month after surgery.
Method of measurement
SPECT-CT Scan
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
Before anesthesia induction, one minute after off pump, one hour after off pump, 8 and 24 hour after surgery
Method of measurement
Heart Monitoring
2
Description
Diastolic blood pressure
Timepoint
Before anesthesia induction, one minute after off pump, one hour after off pump, 8 and 24 hour after surgery.
Method of measurement
Heart Monitoring
3
Description
Mean arterial pressure
Timepoint
Before anesthesia induction, one minute after off pump, one hour after off pump, 8 and 24 hour after surgery.
Method of measurement
Heart Monitoring
4
Description
Heart rate
Timepoint
Before anesthesia induction, one minute after off pump, one hour after off pump, 8 and 24 hour after surgery.
Method of measurement
Heart Monitoring
Intervention groups
1
Description
Intervention: after induction of anesthesia in intervention group, the patient will receive oxygen (2Lit/min) and sevofluran(4%) during coronary bypass surgery.
Category
Treatment - Drugs
2
Description
Control: after induction of anesthesia in control group, the patient will receive oxygen(2Lit/min).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Center of Boushehr
Full name of responsible person
Dr.Anvaripour
Street address
Cardiac Center of Boushehr
City
Boushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr Medical Scinces University
Full name of responsible person
Afshin Ostovar
Street address
Bushehr Medical Scinces University,Sanggi,Bushehr
City
Boushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr Medical Scinces 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
Boushehr Medical Scinces University
Full name of responsible person
Dr.Anvaripour
Position
Anesthesia Department Assisstance
Other areas of specialty/work
Street address
Boushehr Cardiac Center
City
Boushehr
Postal code
Phone
+98 77 3345 0178
Fax
Email
sina_rezaei_70@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr Medical Scinces University
Full name of responsible person
Dr.Anvaripour
Position
Anesthesia Department Assisstance
Other areas of specialty/work
Street address
Boushehr cardiac Center
City
Boushehr
Postal code
Phone
+98 77 3345 0178
Fax
Email
sina_rezaei_70@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr Medical Scinces University
Full name of responsible person
Dr.Anvaripour
Position
Anesthesia Department Assisstance
Other areas of specialty/work
Street address
Boushehr Cardiac Center
City
Boushehr
Postal code
Phone
+98 77 3345 0178
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)