This randomized, double-blind study will do in patients who was 60 -20 years old with ASA I and for septoplasty surgery admitted to Army 501 Hospital . Patients with random allocation of sampling and using black cards (Group A) and white (group two) are divided into two groups of 30 people.In both groups after induction of identical anesthesia to reduce the amount of intraoperative bleeding, without the surgeon, anesthesiologist and patient data collecter knowledge from syringes content, for Black Cards patients (syringe A) content of the syringe as lidocaine soaked in adrenaline just 1 in 100 thousand routine and in the white card patients (syringe B) content in addition to lidocaine and adrenaline syringe containing 100 mg of transamin. After the start of operation variables study by a person responsible for collecting information regarding the contents of the syringe, are recorded in the questionnaire. In this study, to determine surgeon satisfaction of at least satisfaction and the number 5 represents the number 0 and 10 equivalent full satisfaction expressed moderate satisfaction. Also on the visual analog scale for determining the amount of bleeding Scoring the practice field or position in terms of suitability to operate digit 0 is equivalent to a minimum of bleeding and digit 5 represents the average rate of bleeding and digit 10 represent excessive bleeding
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604145536N6
Registration date:2016-05-15, 1395/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-15, 1395/02/26
Registrant information
Name
Mohamadreza Rafiei
Name of organization / entity
Artesh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8933
Email address
mo_rafiei@armyums.ac.ir
Recruitment status
Recruitment complete
Funding source
Army University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local injection of tranexamic acid in septoplasty surgery position on blood loss during surgery
Public title
Effect of local injection of tranexamic acid on blood loss
Purpose
Prevention
Inclusion/Exclusion criteria
Exclusion criteria: over 60 years old patients with ASAI
Including criteria: ASA Class III, II and IV patients , patients with bleeding disorders, history of thromboembolism, low platelet counts and with impaired coagulation tests (PT and PTT)
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Army University of Medical Sciences
Street address
west fatemi-etemadzadeh
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.AJAUMS.REC.1394.45
Health conditions studied
1
Description of health condition studied
Septoplasty
ICD-10 code
J34.2
ICD-10 code description
Deflection or deviation of septum (nasal)(acquired)
Primary outcomes
1
Description
Bleeding after septoplasty
Timepoint
After operation
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
For black card patients (syringe A) soaked lidocaine to adrenaline will inject 1 in 100000
Category
Treatment - Drugs
2
Description
In white card patients (syringe B) in addition to lidocaine and adrenalin, 100 mg of trans-amine will inject
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
501 AJA Hospital
Full name of responsible person
Dr. Mohamadreza Rafiei
Street address
West fatemi street, Etemadzadeh street, Artesh Unversity of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Research director, Faculty of Medicine
Street address
West fatemi, Etemadzadeh st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Army 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
Army University of Medical Sciences
Full name of responsible person
Dr. Mohamadreza Rafiei
Position
Specialty board of anesthesia & ICU
Other areas of specialty/work
Street address
west fatemi-etemadzadeh
City
Tehran
Postal code
Phone
+98 218158177365
Fax
Email
mo_rafiei@armyums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Dr. Mohamadreza Rafiei
Position
Specialty board of anesthesia & ICU
Other areas of specialty/work
Street address
west fatemi-etemadzadeh
City
Tehran
Postal code
Phone
+98 218158177365
Fax
Email
mo_rafiei@armyums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Dr. Mohamadreza Rafiei
Position
Specialty board of anesthesia & ICU
Other areas of specialty/work
Street address
West fatemi st., Etemadzadeh st.
City
Tehran
Postal code
Phone
+98 218158177365
Fax
Email
mo_rafiei@armyums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)