Comparison of changes in serum interleukin, in patients with morbid obesity under laparoscopic gastric bypass surgery, before and after general anesthesia with isoflurane and propofol.
The porpose of this study is to compare changes in serum Interleukin, in patients with morbid obesity undergoing laparoscopic gastric bypass surgery, is before and after general anesthesia with isoflurane and propofol. 32 patients undergoing laparoscopic gastric bypass referring to Hazrat Rasoul Hospital as a random, double-blind, without control with placebo and with phase 1-2 trials using block randomization and parallel divided into two groups. Patients should be ASA II -III and have morbid obesity (BMI> = 35 kg / m2). Patients with cardiovascular and respiratory diseases, renal failure, diabetes and diseases of the name and the number of white blood cells more than 10 thousand patients are be excluded. After pre-oxygenation, anesthesia induction and patient intubation, as the maintenance of anesthesia during the operation,in first group isoflurane is used and in second group propofol is used intravenously.Then in both groups, interluekin 10 and TNFα by ELISA method is measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111812642N22
Registration date:2015-12-03, 1394/09/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-03, 1394/09/12
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of changes in serum interleukin, in patients with morbid obesity under laparoscopic gastric bypass surgery, before and after general anesthesia with isoflurane and propofol.
Public title
Serum interleukin changes in gastric bypass surgery, before and after general anesthesia with isoflurane and propofol .
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing laparoscopic gastric bypass; ASA Class II -III; morbid obesity (BMI> = 35 kg / m2); Exclusion criteria: With cardiovascular and respiratory diseases, drug and alcohol abuse, renal failure, liver dysfunction and autoimmune disease, diabetes or asthma disease, regular use of steroids and NSAID; core temperature greater than 37 ° C, the number of cells white More than 10 thousand
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is performed using block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Postal code
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
105 /145/د/93
Health conditions studied
1
Description of health condition studied
Laparoscopic Gastric Bypass
ICD-10 code
E66.8
ICD-10 code description
Morbid obesity
Primary outcomes
1
Description
interleukin 10
Timepoint
Before the induction of anesthesia and end of anesthesia
Method of measurement
In blood plasma sample, by ELISA, according picogeram per mililiter
2
Description
TNF Alfa
Timepoint
Before the induction of anesthesia and end of anesthesia
Method of measurement
In blood plasma sample, by ELISA, according picogeram per mililiter
Secondary outcomes
1
Description
Age
Timepoint
Before entering the study
Method of measurement
Based on the number of years of life on the basis of year
2
Description
Height
Timepoint
Before enteiring to study
Method of measurement
Based on the information in the file and on the basis of centimeter
3
Description
wieght
Timepoint
Before entering to study
Method of measurement
Based on the information in the file and on the basis of kilogeram
Intervention groups
1
Description
In the first group, 1.2% isoflurane is used as a maintenance of anesthesia during surgery.
Category
Prevention
2
Description
In the second group, intravenous propofol is used as a maintenance of anesthesia during surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Valiolah Hasani
Street address
Satarkhan Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Alijavad Musavi
Street address
Vice chancellor for research of Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Razi Vaccine and Serum Research Institute
Full name of responsible person
Seyed Reza Bani Hashemi
Position
Immunologist
Other areas of specialty/work
Street address
Hesarak
City
Karaj
Province
Alborz
Postal code
Phone
00982634570038
Fax
Email
R.banihashemi@rvsri.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology group of Iran University of Medical Sciences
Full name of responsible person
Valiolah Hasani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Harat Rasool Hospital, Satarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 5001
Fax
Email
Hassani.v@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology group of Shahid beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)