Protocol summary

Summary
This is a randomized double–blind clinical trial (in terms of the patients, surgeon and researcher) which investigates patients who undergone open septorhinoplasty in Amiarlmoemenin hospital, Rasht. The condition to enter this study is indication of septorhinoplasty and conditions to exit this study are patients’ disagreement to take part in the study, past allergic reaction to lidocaine or tranexamic acid, uncontrolled blood pressure(MAP>120, SBP>160), aspirin or any anticoagulant or anti-platelet agent intake, past history of thrombophilia or thromboembolic accidents, any abnormality in investigations which include PT, PTT, INR>1 before surgery, color vision disturbance and positive seizure history. After taking written consent from patients, 196 patients are divided into two groups (who receive placebo is P, and who receive drug is T) by an operating technician who is blinded based on a computerized program.Demographic information of the patients which consist of sex, age, height, weight, past medical history and drug history are registered. Patients undergo a general anesthesia with the same method, in T group lidocaine 2% 5ml, Aqua destillata 2.5ml, adrenaline 1/10000 0.1ml, Tranexamic acid 10% 2.5 ml, and in P group lidocaine 2% 5ml, Aqua destillata 5ml, adrenaline 1/10000 0.1ml, will be used to induce local anesthesia. Then to induce loacal anesthesia, the anesthesia solution will be injected as below: 2 ml into septum, 2 ml into the incision site, 1-1.5 ml into hump site, 2-2.5 ml into lateral osteotomy site. Septorhinoplasty is performed by an ENT specialist with standard method. Bleeding from operation site is evaluated by ml based on blood volume suctioned and the satisfaction of ENT specialist from operation site is a number from 1 to 3, 1: good (mild bleeding), 2: moderate (bleeding is present but does not interfere with operation process), 3: bad (severe bleeding causes operation site to be unclear to the surgeon). Finally, the volume of the serum used for washing operation site is reduced from the total volume of the liquid in the suction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701291138N24
Registration date: 2017-02-20, 1395/12/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Vice Chancellor for Resarch
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Local Tranexamic Acid on Reducing of Hemorrhage During and After Septorhinoplasty
Public title
The Effects of Local Tranexamic Acid on Reducing of Hemorrhage in Septorhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:The condition to enter this study is indication of septorhinoplasty; Exclusion criteria: patients’ disagreement to take part in the study; past allergic reaction to lidocaine or tranexamic acid; uncontrolled blood pressure(MAP>120, SBP>160); aspirin or any anticoagulant or anti-platelet agent intake; past history of thrombophilia or thromboembolic accidents; any abnormality in investigations which include PT, PTT, INR>1 before surgery; color vision disturbance and positive seizure history;
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 196
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Tehran avenue
City
Raht
Postal code
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.GUMS.REC.1395.22

Health conditions studied

1

Description of health condition studied
Hemorrhage
ICD-10 code
I84
ICD-10 code description
Haemorrhoids

Primary outcomes

1

Description
The volume of bleeding during surgery
Timepoint
During surgery
Method of measurement
Blood volume suctioned by ml

2

Description
The volume of bleeding after surgery
Timepoint
The first 24 hours after surgery
Method of measurement
The number of Gauze and Volume of bleeding(Likert scale)

Secondary outcomes

1

Description
Surgeon Satisfaction
Timepoint
During surgery
Method of measurement
Likert scale

Intervention groups

1

Description
Group T: 2.5 ml Aqua destillata,5 ml Lidocain 2%, 0.1 ml Adrenalin1/100000, 2.5ml Tranexamic Acid 10%
Category
Prevention

2

Description
Group P: 5 ml Aqua destillata,5 ml Lidocain 2%, 0.1ml Adrenalin1/100000
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan University of Medical Sciences
Full name of responsible person
Dr Ali Faghih Habibi
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences, Vice Chancellor for Resarch
Full name of responsible person
Susan Komaee
Street address
Vice-chancellor for Research Building, Opposite of Sepah Bank, Shahid Beheshti Blvd(west)
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences, Vice Chancellor for Resarch
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
Guilan University of Medical Sciences
Full name of responsible person
Dr Ali Faghih Habibi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
dr.faghih.habibi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Ali Faghih Habibi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
dr.faghih.habibi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Fatemeh Nezamdoust
Position
Msc
Other areas of specialty/work
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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