Comparison of the effect of spinal anesthesia and general anesthesia on inflammatory cytokines following ischemic changes caused by tourniquet reperfusion in lower extremity surgery
To compare the effect of spinal anesthesia and general anesthesia on inflammatory cytokines following ischemic changes caused by tourniquet reperfusion in lower extremity surgery
Design
A total of 52 patients in need of surgery, admitted to Imam Reza Hospital of Birjand, who are eligible to enter the study are selected and assigned to spinal anesthesia or general anesthesia groups via simple randomization methods.
Settings and conduct
The study will be performed in the operating room of Imam Reza Hospital in Birjand.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. ASA grade I or II
2. Age range of 25 to 65 years
3. Use of tourniquet on the lower limbs of one side
4. Absence of vascular disease
5. No cardiorespiratory disease
Exclusion Criteria:
1. Duration of surgery less than 60 minutes or more than 90 minutes
2. Need for re-operation
3. Patient's unwillingness to cooperate in each stage of study
4. Patient's death
Intervention groups
There are two intervention groups in this study. In the spinal anesthesia, a blood sample will be collected before anesthesia, and the patient will undergo spinal anesthesia. In the general anesthesia group, a blood sample will be collected before anesthesia and then the patient will undergo general anesthesia. Before surgery and 12 and 48 hours after surgery, blood samples will be collected in both groups.
Main outcome variables
IL-6 will be tested by an enzyme-linked immunosorbent assay. TNF alpha, hs-CRP, and ferritin will be determined using laboratory kits in the laboratory.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150308021383N10
Registration date:2018-02-11, 1396/11/22
Registration timing:registered_while_recruiting
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Amir Saber Tanha
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2778
Email address
dr.saber@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Birjand University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of spinal anesthesia and general anesthesia on inflammatory cytokines following ischemic changes caused by tourniquet reperfusion in lower extremity surgery
Public title
General or spinal anesthesia for lower limb surgeries with tourniquet
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA grade I or II
Age range of 25 to 65 years
use of tourniquet on the lower limbs of one side
absence of vascular disease
no cardio respiratory disease
absence of renal failure
non-impairment in liver function
non-diabetes or the use of any antioxidant or anti-inflammatory drug
Exclusion criteria:
Duration of surgery less than 60 minutes or more than 90 minutes
Need for re-operation
patient's unwillingness to cooperate in each stage of study
patient's death
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be allocated into one of the two study groups via simple randomization method and will receive the intervention of the group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor and care providers were blind to the allocation groups of participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Birjand University of Medical Sciences
Street address
Vice-chancellery for Research, Birjand University of Medical Sciences, Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
Ir.bums.REC.1396.178
Health conditions studied
1
Description of health condition studied
lowerlimb surgery
ICD-10 code
M84
ICD-10 code description
Disorders of continuity of bone
Primary outcomes
1
Description
serum level of Interlukin 6
Timepoint
Before using tourniquet (T0), 12 hours after surgery (T1), and 48 hours after surgery (T2)
Method of measurement
ELlSA
2
Description
TNFA
Timepoint
Before using tourniquet (T0), 12 hours after surgery (T1), and 48 hours after surgery (T2)
Method of measurement
ELlSA
3
Description
hs-CRP
Timepoint
Before using tourniquet (T0), 12 hours after surgery (T1), and 48 hours after surgery (T2)
Method of measurement
ELlSA
4
Description
ferritin
Timepoint
Before using tourniquet (T0), 12 hours after surgery (T1), and 48 hours after surgery (T2)
Method of measurement
ELlSA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1 (Spinal Anesthesia): A blood sample will be collected before anesthesia. The patient will undergo spinal anesthesia. Before surgery and 12 and 48 hours after surgery, blood samples will be collected.
Category
Treatment - Drugs
2
Description
Intervention Group 2 (General Anesthesia): A blood sample will be collected before anesthesia. The patient will undergo general anesthesia. Before surgery and 12 and 48 hours after surgery, blood samples will be collected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Amir Sabertanha
Street address
Taleghani St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3244 0338
Email
amirsaber43@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
dr.toobakazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Sabertanha
Position
Assistant professor of anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 2778
Fax
Email
dr.saber@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Sabertanha
Position
Assistant professor of anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 2778
Fax
Email
dr.saber@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Sabertanha
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 2778
Fax
Email
dr.saber@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
As part of the informed consent, confidentiality is to be reserved.
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
In the potential paper extracted, such data will be shared.
When the data will become available and for how long
Upon acceptance of the potential paper and as long as the paper is available online.
To whom data/document is available
To all readers of the paper
Under which criteria data/document could be used
Upon conditions mentioned by the journal
From where data/document is obtainable
the journal
What processes are involved for a request to access data/document
Given the data available in the paper and correspondence with authors via email addresses mentioned in the paper