The effect of Tranexamic Acid in decreasing of intraoperative bleeding and need for deliberate hypotension in patients undergoing Functional Endoscopic Sinus Surgery.
The aim of this study is determining the effect of tranexamic acid to reduce intraoperative bleeding in patients undergoing endoscopic sinus surgery. This is a randomized double-blind with a placebo control study . All 16 to 40 years old patients with ASA class 1 in Ahwaz Imam Khomeini hospital that candidate for elective Functional Endoscopic Sinus Surgery are studied. Exclusion criteria were pregnancy and coagulopathy disorders.The sample in this study were calculated 66 patients .Bleeding Calculate by the number of gases and blood soaked into the suction .Patients divided into two groups.Immediately after induction,in case group we infuse 10mg/kg Tranexamic acid in 50cc normal salin in 15 minut and patients in control group recived 50cc normal salin in 15 minut.During the operation the patient's blood pressure is taken every 15 minutes.At the end of surgery all patients reversed and transfered to recovery.In this study we expect decreasing intraoperative bleeding in case group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111411455N1
Registration date:2013-03-17, 1391/12/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-17, 1391/12/27
Registrant information
Name
Hamidreza Deylamani
Name of organization / entity
Ahvaz (Jondishapour) University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
deylamani.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz (Jondishapour) University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tranexamic Acid in decreasing of intraoperative bleeding and need for deliberate hypotension in patients undergoing Functional Endoscopic Sinus Surgery.
Public title
The effect of Tranexamic Acid in decreasing of bleeding in patients undergoing Functional Endoscopic Sinus Surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:16_40 years olds ASA class1 with crhonic sinusitis canditate for surgery. Exclusion criteria:Pregnancy ; anticoagulant therapy at recent 3 mounts ; patients with coagulopathy.
Age
From 16 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Ahvaz (Jondishapour) University of Medical Sciences
Street address
Golestan
City
Ahvaz
Postal code
Approval date
2012-06-30, 1391/04/10
Ethics committee reference number
Eth-528
Health conditions studied
1
Description of health condition studied
Bleeding
ICD-10 code
T81.0
ICD-10 code description
Haemorrhage and haematoma complicating a procedure, not elsewhere classified
Primary outcomes
1
Description
Intraoperative bleeding
Timepoint
During the surgery
Method of measurement
Number of gases and soaked blood into the suction by miili liter
Secondary outcomes
1
Description
Intraoperative blood pressure
Timepoint
Every 15 minute
Method of measurement
Automated sphygmomanometer by mmhg
Intervention groups
1
Description
In intervention group 33 patients 10 mg/kg tranexamic acid in 50 cc normal salin infuse within 15 minute .
Category
Treatment - Drugs
2
Description
In control group 33 patients 50cc normal salin infuse within 15 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Hamidreza Deylamani
Street address
Azadegan Avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz (Jondishapour) University of Medical Sciences
Full name of responsible person
Mostafa Feghhi.MD
Street address
Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz (Jondishapour) 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
Imam Khomini hospital
Full name of responsible person
Hamidreza Deylamani
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
deylamani.h@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomini Hospital
Full name of responsible person
Ali Ghomeishi.MD
Position
Assistant Professor of Department of Anesthesiology
Other areas of specialty/work
Street address
Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
deylamani.h@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Khomini Hospital
Full name of responsible person
Hamidreza Deylamani.MD
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
deylamani.h@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)