Protocol summary

Summary
Objectives:The aim of this study is to compare the effects of propofol and isoflurane, both supplemented with sufentanil, on the stress response in coronary artery bypass grafting surgery with cardiopulmonary bypass, using cortisol as a biochemical marker Design: This double-blind randomized clinical trial will conduct on patients who undergo CABG surgery after obtaining the informed consent and approved by the Institutional Ethics Committee of Guilan University of Medical Science. Setting and Conduct: Because of maximum cortisol level occurs in early morning , All samples will take on the morning between 7:30 am to 8:30 am. Participants: Inclusion criteria: 72 patients classified upscale 65-18 year old, physical status (ASA class) II-III, in year between 2014-2015 ,who underwent elective bypass surgery after coronary artery disease (3 vessels) with cardiopulmonary pump will enroll in the study . In any case of following problem the patients don’t meet the inclusion criteria, they don’t enter into study: emergency surgery, liver-kidney disease, neurology, diabetes, thyroid, use of corticosteroids and other drugs that suppress the immune , obesity (BMI≥30), addiction to alcohol and drugs. Exclusion criteria: Any complication during surgery, bleeding, arrhythmia resistant to conventional treatment, duration of contact pump over 100 minutes, hematocrit less than 25%, intubation prolonged intensive care unit, drug use( sympathomimetic) to disconnect the patient from the pump (epinephrine, norepinephrine) and the use of IABP patients were excluded from the study. Intervention: This study will perform in double blind setting and the patients will randomly allocate to select the cards I (isoflurane group) or cart P (propofol group) to receive( isoflorane-sufentanil ) or (Propofol-sufentanil). outcome variable :Levels of blood cortisol will measure half an hour before transfer to the operating room and given premedication (T0), after heart-lung pump (T1) and 24 hours after the surgery (T2).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015071713456N5
Registration date: 2015-09-14, 1394/06/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-14, 1394/06/23
Registrant information
Name
Abbas Sedighinejad
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 132 5712
Email address
a_sedighinejad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Guilan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-12-06, 1394/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Isoflurane-Sufentanil Anesthesia and Propofol-Sufentanil Anesthesia on Serum Cortisol Levels in Open Heart Surgery with Cardiopulmonary Bypass
Public title
Comparing the Effects of Isoflurane-Sufentanil Anesthesia and Propofol-Sufentanil Anesthesia on Serum Cortisol Levels in Open Heart Surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria:72 patients 18-65 years old with ASA classII-III who undergo CABGs with cardiopulmonary bypass; All samples will take on the morning between 7:30 am to 8:30 am. Exclusion Criteria : Emergency surgery; Hepatic or Renal failure; Neurologic Disorders; Diabetes; Malignancies; BMI>38 kg/m2; Steroid therapy before operation; Chronic Drug abuse; Thyroid dysfunction and Redo operation; sever hemorrhage ; arrhythmia resistant to treatment ;time of CPB over than 100 min ; Hct<25%;prolonged intubation in ICU; use of sympathomimetic drug to treat or help IABP and weaning(epinphrine ,norepinephrine)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 72
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
Ethical Comeetee of Guilan University of Medical Sciences
Street address
Deputy department, Namjoo Avenue
City
Rasht
Postal code
4193833697
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
1920422816

Health conditions studied

1

Description of health condition studied
Cronary Artery Disease Three Vessel Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease Coronary (artery): atherosclerosis

Primary outcomes

1

Description
Blood Cortisol Level
Timepoint
Preoperative ,cardiopulmonary Bypass,24 hour after surgery
Method of measurement
the blood cortisol level mcg/litr

Secondary outcomes

1

Description
Mean Arterial Pressure (mmhg)
Timepoint
Preoperative,During CPB and After 24 hours)
Method of measurement
with monitoring of blood pressure

Intervention groups

1

Description
In I group anesthesia will maintaine with 1-1.5% of volatile anesthetitc , isoflurane and sufantanil 0.1-0.3 µg/kg/h and 0.6 mg/kg/h cisatracurium.
Category
Treatment - Drugs

2

Description
In P group anesthesia will maintain by continuous infusion of propofol 50-150 mg/kg/min isoflurane and sufantanil 0.1-0.3 µg/kg/h and 0.6 mg/kg/h cisatracurium.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Heshmat ,the Heart hospital ,Teaching and Research Center
Full name of responsible person
Dr Abbas Sedighinejad
Street address
DR Heshmat hospital,Bayani Crossroad,shahid Beheshti Hiway.
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellaor for Research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heydarzadeh Dr
Street address
GAZ square,the first of shahid Beheshty high way.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellaor for Research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Abbas Sedighinejad
Position
Associated Professor
Other areas of specialty/work
Street address
Anesthesiology Research Centre,velayat hospital,,Crossroads Poursina,Namjoo st.
City
Rasht
Postal code
4193713189
Phone
+98 13 1321 0434
Fax
Email
a_sedighinejad@yahoo.com; a_sedighinejad@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abbas Sedighinejad
Position
Associated Professor
Other areas of specialty/work
Street address
Anesthesiology Research Center,Velayat hospital,crossroad poursina Rasht
City
Rasht
Postal code
4193713189
Phone
+98 13 1321 0434
Fax
Email
a_sedighinejad@yahoo.com;a_sedighinejad@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Associated Professor
Other areas of specialty/work
Street address
Anesthesiology Research Center,Velayat Hospital,Crossroad Poursina.
City
Rasht
Postal code
Phone
+98 139113315256
Fax
Email
manesthesist@gmail.com
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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