The patients are randomly allocated to intervention and placebo groups. In placebo group, torniquet in placed on the contralateral thigh but not inflated. In the intervention group, torniquet is inflated up to 20 mmHg higher than systolic blood pressure for 5 minutes. This procedure is repeated for three times with five min rest between inflations. IL-10 is measured after torniquet deflation in both groups.
Outcomes measures include blood pressure, pulse rate, pulse oximetry and ABG parameters. These data are recorded before torniquet inflation, and after inflation in 10 min intervals up to 30 minutes. The duration of torniquet inflation and surgery, blood loss and maintenance fluids are also recorded by the anesthesia resident.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304055026N2
Registration date:2013-04-12, 1392/01/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-12, 1392/01/23
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences (Thesis and research project budget)
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ischemic preconditioning on IL-10, hemodynamic and pulmonary indices after deflation of surgical torniquet
Public title
Reducing the cardiopulmonary complications of orthopedic surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: elective cases of lower extremity fractures candidate of surgery with torniquet inflation more than 1 hr and ASA physical status I-III.
Exclusion criteria: head/chest trauma; contra lateral fracture; deep sedation required (more than 1 mg midazolam); inadequate level of spinal anesthesia; High spinal anesthesia and addict patients.
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Hemmat Blv.
City
Tehran
Postal code
Approval date
2013-03-10, 1391/12/20
Ethics committee reference number
91-04-30-20020
Health conditions studied
1
Description of health condition studied
Hypotension
ICD-10 code
I98.8
ICD-10 code description
Other specified disorders of circulatory system in diseases classified elsewhere
2
Description of health condition studied
hypoxemia
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Acute lung injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure
Timepoint
Before cuff inflation and after cuff deflation in 10 min intervals up to 30 min
Method of measurement
mmHg
2
Description
Heart rate
Timepoint
Before cuff inflation and after cuff deflation in 10 min intervals up to 30 min
Method of measurement
ECG monitoring
3
Description
Arterial oxygen saturation
Timepoint
Before cuff inflation and after cuff deflation in 10 min intervals up to 30 min
Method of measurement
Pulse oximetry
Secondary outcomes
1
Description
IL-10
Timepoint
Before cuff inflation and after cuff deflation
Method of measurement
ELISA
Intervention groups
1
Description
In the intervention group, torniquet is inflated up to 20 mmHg higher than systolic blood pressure for 5 minutes. This procedure is repeated for three times with five min rest between inflations.
Category
Treatment - Other
2
Description
In placebo group, torniquet in placed on the contralateral thigh but not inflated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Medical Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Scienes
Full name of responsible person
Akbar Fotouhi
Street address
6th floor, Tehran University of medical sciences, Ghods Ave., Keshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Scienes
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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Jamshidi
Position
MD, Resident of anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Rasoul Akram Medical Center, Sattarkhan St
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
dr.jamshidi78@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Rasould Akram Medical Center, Sattar khan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
masood.mohseni@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
masood mohseni
Position
Assistant professor of anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Rasoul Akram Medical Center, Sattarkhan St,
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
masood.mohseni@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)