Aim: Evaluation of the intravenous tranexamic acid effect on blood loss and surgical field quality during nasal surgery.
Design: Double blinded randomized controlled trial.
Setting: The eligible patients with nasal surgery who will refer to ENT clinic of Besat hospital in 2013.
Inclusion criteria: (a) patients with nasal surgery; (b) age of 18 to 75 years; (c) ASA ≤ II.
Exclusion criteria: (a) Patient refuse; (b) abnormal coagulation test; (c) surgery time less than 30 minutes (d) history of thrombosis or deep vein thrombosis; (e) acute or chronic renal failure; (f) ischemic heart disease and arrhythmia; (g) history of seizure; (h) allergy to tranexamic acid; (i) usage herbal medications; (j) pregnancy; (k) color blind.
Intervention: During nasal operation 35 patients will receive 500 mg intravenous tranexamic acid mixed up in 500ml lactated Ringer's solution with concentration 1mg/ml and maximum infusion rate 100mg/min and maximum dosage 15mg/kg.
Control: During nasal operation 35 patients will receive lactated Ringer's solution as maintenance therapy.
Primary outcome: (a) quality of surgical field every 20 minutes during surgery using Boezzart scale; (b) determine blood volume accumulated in the suction chamber after operation; (c) changes hemoglobin and hematocrit 6 hours after surgery; (d) satisfactory of surgeon at end of operation.
Secondary outcome: measurement of (a) seizure; (b) nausea; (c) vomiting; (d) and impaired color vision 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012911822N3
Registration date:2013-03-09, 1391/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-09, 1391/12/19
Registrant information
Name
Behrooz Karkhanei
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0574
Email address
karkhanei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the intravenous tranexamic acid effect on blood loss and surgical field quality during nasal surgery
Public title
Evaluation of the intravenous tranexamic acid effect on blood loss and surgical field quality during nasal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Nasal surgery; 18 to 65 years old; ASA ≤ II
Exclusion criteria: Patient refuse; Surgery time less than 30 minutes; Renal dysfunction; Impaired color vision; Abnormal coagulation test; History of thrombosis or deep vein thrombosis; Ischemic heart disease and arrhythmia; Central nerve system disorder; Allergy to tranexamic acid; Usage Herbal medications; Pregnancy
Age
From 18 years old to 65 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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Subject Review Board
Street address
Shaheed Famideh Street, Hamadan University Of Medical Sciences
City
Hamadan
Postal code
6517838695
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
D/P/16/35/9/4021
Health conditions studied
1
Description of health condition studied
heamorrhage
ICD-10 code
Y60.0
ICD-10 code description
Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care During surgical operation
Primary outcomes
1
Description
volume of blood in suction bottle
Timepoint
At end of surgery
Method of measurement
Viewing chamber volume per ml
2
Description
Quality of hemorrhage
Timepoint
each 20 min.
Method of measurement
Boezzart criteria
3
Description
Hematocrit
Timepoint
Preoperative and six hours postoperative
Method of measurement
Automated Cell Counter
4
Description
hemoglobin
Timepoint
Preoperative and six hours postoperative
Method of measurement
Automated Cell Counter
5
Description
Satisfactory of surgeon from bleeding
Timepoint
At end of surgery
Method of measurement
ask the surgeon
Secondary outcomes
1
Description
impaired color vision
Timepoint
the day after sugery
Method of measurement
Ask the patient
2
Description
Nausea
Timepoint
The day after sugery
Method of measurement
Ask the patient
3
Description
Vomiting
Timepoint
The day after sugery
Method of measurement
Ask the patient
4
Description
Seizure
Timepoint
The day after sugery
Method of measurement
observation of the patient
Intervention groups
1
Description
During nasal operation, patients will receive 500 mg intravenous tranexamic acid mixed up in 500ml lactated Ringer's solution with concentration 1mg/ml and maximum infusion rate 100mg/min and maximum dosage 15mg/kg.
Category
Treatment - Drugs
2
Description
During nasal operation, control patients will receive lactated Ringer's solution as maintenance therapy.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Behrooz Karkhanei
Street address
Besat Hospital, Imam Hossein Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Hamadan University of Medical Science
Full name of responsible person
Ahmad Tavilani
Street address
Hamadan University of Medical Sciences, Vice chancellor for Research and Technology, Shaheed Fahmideh St.
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 and Technology, Hamadan University of Medical Science
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
Hamadan University of Medical sciences
Full name of responsible person
Behrooz Karkhanei
Position
MD. Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Medicine faculty, Hamadan University of Medical sciences, Shaheed Fahmideh St.
City
Hamadan
Postal code
Phone
+98 81 1838 0574
Fax
karkhanei@umsha.ac.ir
Email
karkhanei@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Behrooz Karkhanei
Position
MD. Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Medicine faculty, Hamadan University of Medical sciences, Shaheed Fahmideh St.
City
Hamadan
Postal code
Phone
+98 81 1838 0574
Fax
Email
karkhanei@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Salahaddin ghaderi
Position
Medical student
Other areas of specialty/work
Street address
Medicine faculty, Hamadan University of Medical sciences, Shaheed Fahmideh St.
City
Hamadan
Postal code
Phone
+98 81 1838 0574
Fax
Email
salahghaderi@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)