Evaluating the Effect of Dexmedetomidine Infusion on Gene Expression of Inflammatory Cytokines & Lymphocyte T CD4 + Transcription Factors in Elective Abdominal Aortic Aneurysm Repair
The aim of this study was to evaluate the effect of Dexmedetomidine infusion on the expression of inflammatory cytokines and transcription factors of T lymphocytes during elective surgery of abdominal aortic aneurysm.
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment,
Settings and conduct
Shohada Tajrish Hospital
Participants/Inclusion and exclusion criteria
Entry into the study of candidates for elective abdominal aortic surgery and the rate of emergency exit surgery and any unpredictable conditions during surgery
Intervention groups
The subjects undergoing anesthesia induction with doses of 0.3mcg / kg / hour doses of doxedemotomidine until aortic clamp and the control group did not receive doxedetomidine infusion
Main outcome variables
The relative level of mRNA lL-6; The relative level of TNF-α mRNA; Relative level of IL-1 mRNA; Relative level of T-beT mRNA; Relative level of ROR-T mRNA; Relative level of GATA-3 mRNA; Relative level of FOXP3 mRNA
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20190121042444N1
Registration date:2019-06-13, 1398/03/23
Registration timing:registered_while_recruiting
Last update:2019-06-13, 1398/03/23
Update count:0
Registration date
2019-06-13, 1398/03/23
Registrant information
Name
faranak behnaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1174
Email address
faranak.behnaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Dexmedetomidine Infusion on Gene Expression of Inflammatory Cytokines & Lymphocyte T CD4 + Transcription Factors in Elective Abdominal Aortic Aneurysm Repair
Public title
Evaluating the Effect of Dexmedetomidine Infusion on Gene Expression of Inflammatory Cytokines & Lymphocyte T CD4 + Transcription Factors in Elective Abdominal Aortic Aneurysm Repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with abdominal aortic aneurysms referring to Shohadaye Tajrish Hospital who are candidates for elective aneurysm repair surgery will be included in the study.
Exclusion criteria:
Previous history of aortic surgery
ASA Class III and above
IBD
Malignancies
Chronic inflammatory diseases
Taking corticosteroids
Emergency surgery
Any unstable patient during surgery
Any addiction
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random numbers, the patient and the individual who fill the table are unaware
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and anesthetist who fill the table are unaware of the study
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Vel'yanjak Ave Shahid Beheshti University
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2018-09-04, 1397/06/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.348
Health conditions studied
1
Description of health condition studied
Abdominal Aortic Aneurysm
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Relative level of mRNA; IL6
Timepoint
Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge
Method of measurement
Sampling from patient's blood and filling in the questionnaire
2
Description
Relative level of mRNA; TNF-α
Timepoint
Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge
Method of measurement
Sampling from patient's blood and filling in the questionnaire
3
Description
Relative level of Foxp3 mRNA
Timepoint
Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge
Method of measurement
Sampling from patient's blood and filling in the questionnaire
4
Description
Relative level of GATA3mRNA
Timepoint
Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge
Method of measurement
Sampling from patient's blood and filling in the questionnaire
5
Description
Relative level of IL-1mRNA
Timepoint
Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge
Method of measurement
Sampling from patient's blood and filling in the questionnaire
6
Description
Relative level of ROR-
Timepoint
Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge
Method of measurement
Sampling from patient's blood and filling in the questionnaire
7
Description
Relative level of T-bet mRNA
Timepoint
Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharg
Method of measurement
Sampling from patient's blood and filling in the questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group was subjected to anxiolytic infusion with doses of 0.3 mg / kg / hour doses of DEX until aortic clamp. Patients' blood samples were taken to determine the level of inflammatory cytokines and the level of expression of inflammatory mRNAs in the preoperative period, after induction of anesthesia, 24 hours after surgery, 4 days after surgery, and at discharge time, from a patient's peripheral blood sample size And the effect of DEX on them will be investigated.
Category
Diagnosis
2
Description
Control group: There are no interventions in this group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
faranak behnaz
Street address
Tajrish Square Hospital Shohada Tajrish
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1174
Fax
+98 21 2274 1174
Email
h.ariannia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
nahid asadi
Street address
Velenjak Av; Yemen Street
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2243 2572
Email
nahidasasadi25@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
25
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
faranak behnaz
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
tajrish Sq;shohada hospital
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1174
Email
faranak.behnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
faranak behnaz
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
tajrish Sq;shohada hospital
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1174
Email
faranak.behnaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
nahid asadi
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
velenjak Av ;anesthesiology reasrch center
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2243 2572
Email
nahidasadi25@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
1399
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Analyzes on the delivered data are allowed
From where data/document is obtainable
Shohada Tajrish Hospital Department of Anesthesiology - Maidan Tajrish Building No. 1 Second Floor Operation Room Dr. Behnaz Telephone 22741174
Shohada Tajrish Hospital - Tajrish Square Building No. 1 Second Floor Ms. َ Arinnia Telephone 22718002 Internal 310
What processes are involved for a request to access data/document