Comparison of the effect of oral tranexamic acid and corticosteroid on blood loos and the quality of the surgical field during endoscopic sinus surgery
The aim of this study is comparing the effect corticosteroid and tranexamic acid on the bleeding and quality of surgery zone in the nasal sinus endoscopy. This is randomized clinical trail.
Inclusion criteria consist of patients with ASA class 1 and 2 with age 15 - 75 year-old and exclusion criteria consist of patients with sensitivity or contraindications to corticosteroid and tranexamic acid.
90 patients were enrolled the study and randomly divided in to 3 groups. In the first group, 1gr oral tranexamic acid was administrated two hours before the surgery and in the second group, 1mgr/kg/day oral prednisolon was administrated for 5 days and the third group will not receive any drug, then the quality of the surgery zone and volume of the bleeding at the end of the surgery will compared between three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031016924N1
Registration date:2016-06-28, 1395/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-28, 1395/04/08
Registrant information
Name
Nasim Valizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
valizadeh-na@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sicences Kashan, Vice chancellor for research
Expected recruitment start date
2013-10-10, 1392/07/18
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral tranexamic acid and corticosteroid on blood loos and the quality of the surgical field during endoscopic sinus surgery
Public title
Comparison of the effect of oral tranexamic acid and corticosteroid on blood loos and the quality of the surgical field during endoscopic sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with ASA class 1 and 2; aged between 15 to 75 year-old; hemoglobin level more than 10 mg/dl. Exclusion criteria: sensitivity or contraindication of use corticosteroids and tranexamic acid; history of clotting disorders; previous operation at the same region; uncontrolled hypertension; consuming of corticosteroids in last 2 months .
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical sciences, 5 km ghotbeh Ravandi Boulevard, Kashan, Isfahan
City
Kashan
Postal code
87159/81151
Approval date
2013-10-09, 1392/07/17
Ethics committee reference number
پ/29/5/1/2972
Health conditions studied
1
Description of health condition studied
chronic sinusitis
ICD-10 code
Chronic si
ICD-10 code description
J32.0, J32.1
Primary outcomes
1
Description
Intraoperative blood loss volume
Timepoint
At the end of surgery
Method of measurement
The amount of the accumulated blood volume in the suction and the surgery field
2
Description
Quality of the surgery field
Timepoint
During surgery
Method of measurement
Endoscopy
Secondary outcomes
1
Description
Intraoperative intravenous fluid intake
Timepoint
Every 30 minutes during surgery
Method of measurement
Administered fluid volume
Intervention groups
1
Description
Group 1: Cap 250 mg tranexamic acid 1 gr orally 2 hours before surgery
Category
Treatment - Drugs
2
Description
Group 2: Tab Prednisolone 50 mg with doses 1 mg / kg per day orally for 5 days before surgery
Category
Treatment - Drugs
3
Description
Group 3: will not receive any drug
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Matini Hospital
Full name of responsible person
Dr.Mohammad Reza Fazel
Street address
Amir Kabir Avenue, Kashan, Isfahan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical sciences
Full name of responsible person
Dr.Gholam Ali Hamidi
Street address
Kashan University of Medical sciences, 5 km ghotbeh Ravandi boulevard, Kashan, Isfahan
City
Kashan
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, Kashan 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
Kashan university of medical sciences
Full name of responsible person
Nasim Valizadeh
Position
Anesthesia resident
Other areas of specialty/work
Street address
Kashan University of Medical sciences, 5 km ghotbeh Ravandi Boulevard, Kashan, Isfahan
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
valizadeh-na@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan university of medical sciences
Full name of responsible person
Mohammad reza Fazel
Position
Anesthesiologist
Other areas of specialty/work
Street address
Kashan University of Medical sciences, 5 km ghotbeh Ravandi Boulevard, Kashan, Isfahan
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
drm fazel@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan university of meical sciences
Full name of responsible person
Nasim Valizadeh
Position
Anesthesia resident
Other areas of specialty/work
Street address
Kashan University of Medical sciences, 5 km ghotbeh Ravandi Boulevard, Kashan, Isfahan
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
valizadeh-na@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)