This study planed to compare the effects of two doses of intravenous tranexamic acid on amount of bleeding and quality of the field of the surgery during endoscopic sinus surgery. After Ethics Committee approval and patients written informed consent ,70 patients ASA physical status I or II who are candidates for endoscopic sinus surgery under general anesthesia were recruited in this randomized, double-blind study.After induction of anesthesia with propofol and atracurium and tracheal intubation (the same for all the patients) the patients in two groups received randomly 5 mg/kg or 15 mg/kg intravenous tranexamic acid(souluted in 100 ml of normal saline) as the infusion during 10 minutes . Systolic,diastolic and mean arterial blood pressures and pulse rate are recorded before induction of anesthesia and then 30 , 60 ,90 ,120 ,120 and 180 minutes after that. Also quality of the feild of surgery according to Boezarrt score and satisfaction of the surgeon according to Likertt score are assessed in these times.If the patients need the additional intervention like administration of intravenous TNG to control the intraoperative bleeding ,this is recorded.At the end of the surgery the total amount of blood loss during the surgery and duration of the surgery are reccorded too.Drug side effects (nausea,vomiting ,diarrhea ,abdominal pain and thrombotic complications) evalueded and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203242963N7
Registration date:2012-04-06, 1391/01/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-06, 1391/01/18
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2011-09-13, 1390/06/22
Expected recruitment end date
2012-03-18, 1390/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effects of Two Doses of Intravenous Tranexamic Acid on Blood loss and Feild of the surgery during Endoscopic Sinus Surgery
Public title
Comparison the Effects of Two Doses of Intravenous Tranexamic Acid on Blood loss and Feild of the surgery during Endoscopic Sinus Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA physical status I or II,18-50 aged candidates for endoscopic sinus surgery under general anesthesia
Exclusion criteria:Coagulation disorder,history of hypertension,CVA,deep venous thrombosis,coronary artery disease,pulmonary emboli,and peripheral vascular disease.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2011-09-12, 1390/06/21
Ethics committee reference number
71404
Health conditions studied
1
Description of health condition studied
tranexamic acid
ICD-10 code
Y44.5
ICD-10 code description
Thrombolytic drugs
Primary outcomes
1
Description
Amount of blood loss
Timepoint
at the end of the surgery
Method of measurement
The amount of blool in the suction device and the number of blood-soaked gauze
Secondary outcomes
1
Description
Quality of the feild of surgery
Timepoint
At the end of surgery
Method of measurement
Boezarrt score
Intervention groups
1
Description
Intravenous tranexamic acid 5 mg/kg
Category
Treatment - Drugs
2
Description
Intravenous tranexamic acid 15 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr.Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr, Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)