The aim of this study is the comparison of two doses of tranexamic acid on bleeding duration of surgery and satisfaction of surgeon in sinus endoscopy. Inclusion criteria: all patients 16 to 60 years old with ASA I,II are undergoing sinus endoscopy with no airway complications, systemic diseases or known psychological diseases surgery patients had no history of sensitivity to anesthesia or any other drugs used in this study. Exclusion criterion: the time of operation takes more than 150 minutes. Hundred patients are randomly divided into two groups; the first group, receive 5mg/kg tranexamic acid and the second group receive 10 mg/kg tranexamic acid then systolic and diastolic blood pressure, heart rate measured in 15, 30, 60, 90, 120, 150 minutes, Satisfaction of surgeon, time of surgery and bleeding volume and side effects of drug are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062021436N2
Registration date:2015-07-07, 1394/04/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-07, 1394/04/16
Registrant information
Name
Shideh Marzban
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3727 1717
Email address
sh_marzban@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of different doses of tranexamic acid on amount of bleeding and duration of surgery in sinus endoscopy
Public title
The efficacy of different doses of tranexamic acid on amount of bleeding and duration of surgery in sinus endoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients 16 to 60 years old with ASA I,II are undergoing sinus endoscopy with no airway complications, systemic diseases or known psychological diseases surgery Patients had no history of sensitivity to anesthesia or any other drugs used in this study.
Exclusion criterion: the time of operation takes more than 150 minutes.
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Shahid Beheshti Freeway
City
Rasht
Postal code
4193833697
Approval date
2015-06-09, 1394/03/19
Ethics committee reference number
IR.GUMS.REC.1394.49
Health conditions studied
1
Description of health condition studied
Bleeding, sinus
ICD-10 code
O46.9
ICD-10 code description
Antepartum haemorrhage, unspecified
Primary outcomes
1
Description
Bleeding
Timepoint
15, 30, 60, 90, 120 and 150 minutes after surgery
Method of measurement
Boezaart scale
2
Description
Duration of surgery
Timepoint
At the end of surgery
Method of measurement
Minute
3
Description
Surgeon satisfaction
Timepoint
At the end of surgery
Method of measurement
Likertt scale
Secondary outcomes
empty
Intervention groups
1
Description
First group:infusion of 5mg/kg tranexamic acid
Category
Prevention
2
Description
Second group :infusion of 10mg/kg tranexamic acid
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin
Full name of responsible person
Shideh Marzban
Street address
Fifteenth Khordad Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Shideh Marzban
Position
Anesthesiologist
Other areas of specialty/work
Street address
Amir Al-momenin Hospital
City
Rasht
Postal code
4193955599
Phone
+98 13 3336 8534
Fax
+98 13 3336 8651
Email
sh_marzban@gums.ac.ir
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3336 8534
Fax
+98 13 3336 8534
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)