Effect of local tranexamic acid plus phenylephrine versus phenylephrine alone on reduction of bleeding and improvement of surgical filed during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a double blinded randomized controlled trial
Objectives: To assess the effect of local tranexamic acid on reduction of bleeding and improvement of surgical filed during functional endoscopic sinus surgery in patients with chronic rhinosinusitis
Design: Double blinded randomized controlled trial
Setting and conduct: The eligible patients with chronic rhinosinusitis who will refer to ENT clinic of Besat hospital in 2013
Participants including major eligibility criteria as follows: Inclusion criteria: (a) patients with chronic rhinosinusitis with or without polyposis; (b) age of 18 to 60 years; (c) hemoglobin >10 mg/dl; (d) normal CT, BT, INR, PT, PTT. Exclusion criteria: (a) having hemorrhagic abnormality such as hemophilia; (b) thrombosis; (c) acute or chronic renal failure; (d) using heparin during 48 hours before surgery; (e) using aspirin during three days before surgery; (f) allergy to tranexamic acid; (g) cirrhosis; (h) chronic diseases such as hypertension, diabetes, and heart failure; (i) pregnancy; (j) color blind; (k) having cardiac stent; (l) having nasal tumor.
Intervention: 30 patients will receive three pads impregnated with tranexamic acid 5% and phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery.
Control: 30 patients will receive three pads impregnated only with phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery
Main outcome including: Primary outcomes: (a) quality of surgical field at 15, 30, and 45 minutes after surgery using Boezaart grading with1-5 scores; (b) bleeding at 15, 30, and 45 minutes after surgery using blood accumulated in the suction chamber after reducing the amount of serum used for washing and measurement of nasopharyngeal pack weight and converting the blood weight into ml. Secondary outcomes: measurement of (a) nausea; (b) vomiting; (c) and impaired color vision 24 hours after surgery and three days later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212139014N15
Registration date:2013-08-11, 1392/05/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local tranexamic acid plus phenylephrine versus phenylephrine alone on reduction of bleeding and improvement of surgical filed during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a double blinded randomized controlled trial
Public title
Effect of local tranexamic acid plus phenylephrine versus phenylephrine on reduction of bleeding and improvement of surgical filed during functional endoscopic sinus surgery in patients with chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients with chronic rhinosinusitis with or without polyposis; (b) age of 18 to 60 years; (c) hemoglobin >10 mg/dl; (d) normal CT, BT, INR, PT, PTT.
Exclusion criteria: (a) having hemorrhagic abnormality such as hemophilia; (b) thrombosis; (c) acute or chronic renal failure; (d) using heparin during 48 hours before surgery; (e) using aspirin during three days before surgery; (f) allergy to tranexamic acid; (g) cirrhosis; (h) chronic diseases such as hypertension, diabetes, and heart failure; (i) pregnancy; (j) color blind; (k) having cardiac stent; (l) having nasal tumor.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2013-04-09, 1392/01/20
Ethics committee reference number
D/P/9/35/16
Health conditions studied
1
Description of health condition studied
chronic rhinosinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
Quality of surgical field
Timepoint
15, 30 and 45 minutes after surgery
Method of measurement
using Boezaart grading with1-5 scores
2
Description
Bleeding
Timepoint
0.5 and one hour after surgery
Method of measurement
using blood accumulated in the suction chamber after reducing the amount of serum used for washing and measurement of nasopharyngeal pack weight and converting the blood weight into ml.
Secondary outcomes
1
Description
Nausea
Timepoint
24 hours after surgery and three days later
Method of measurement
questionnaire
2
Description
Vomiting
Timepoint
24 hours after surgery and three days later
Method of measurement
questionnaire
3
Description
Impaired color vision
Timepoint
24 hours after surgery and three days later
Method of measurement
questionnaire
Intervention groups
1
Description
30 patients will receive three pads impregnated with tranexamic acid 5% and phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery
Category
Treatment - Drugs
2
Description
30 patients will receive three pads impregnated only with phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Dr Javaneh Jahanshahi
Street address
Besat Hospital, Imam Hossein Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Sara Pazira
Position
Resident of ENT
Other areas of specialty/work
Street address
Besat Hospital, Imam Hossein Square.
City
Hamadan
Postal code
Phone
00
Fax
Email
S_pazira2009@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Javaneh Jahanshahi
Position
Specialist in ENT
Other areas of specialty/work
Street address
Besat Hospital, Imam Hossein Square
City
Hamadan
Postal code
Phone
00
Fax
Email
J.Jahanshahi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)