1-(Objectives): This study aims to assess the role of intravenous Tranexamic Acid (TA) in reducing intraoperative bleeding during elective open rhinoplasty surgery. 2-(Design): In this single center double blinded study (phase 2) which is conducted in Imam Khomeini hospital affiliated to Ahvaz Jundishapour University of Medical Sciences, ninety-six patients are randomly allocated to one treatment arm with tranexamic acid and one control group. 3-(Setting and Conduct): Subjects are recruited for inclusion during their initial visit in the outpatient setting through an interview. 4-(Participants): Inclusion criteria: Normotensive patients scheduled for elective open rhinoplasty aged 16-42 years without a history of bleeding diathesis with ASA (American Society of Anesthesiologists) class of either I or II. Exclusion Criterai: patients with uncontrolled hypertension; history of hypersensitivity to tranexamic acid; brain vascular diseases; coronary artery diseases; cardiac dysrhythmia; liver/kidney or metabolic disorders; patients with ASA class of either III or IV. 5-(Interventions): All subjects will undergo open rhinoplasty under general anesthesia with the same surgical team using standard technique; Individuals in the treatment group will receive an intravenous bolus of tranexamic acid (10 milligrams per kilogram of body weight) immediately after anesthesia induction in the operation room, while patients in the control group are administered with normal saline as the placebo. 6-(Primary Outcome Variable): The primary outcome measure is the estimated volume of intraoperative bleeding (measured in mL). No secondary outcome measures are defined.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015092824241N1
Registration date:2015-11-07, 1394/08/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-07, 1394/08/16
Registrant information
Name
leila Mashali
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1292 1839
Email address
mashali_l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of intravenous tranexamic acid on intraoperative bleeding during elective rhinoplasty surgery
Public title
Effect of Tranexamic Acid On intraoperative Bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Normotensive patients scheduled for elective open rhinoplasty aged 16-42 years without a history of bleeding diathesis with ASA (American Society of Anesthesiologists) class of either I or II. Exclusion Criterai: patients with uncontrolled hypertension; history of hypersensitivity to tranexamic acid; brain vascular diseases; coronary artery diseases; cardiac dysrhythmia; liver/kidney or metabolic disorders; patients with ASA class of either III or IV.
Age
From 16 years old to 42 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
A statistician not otherwise involved in the study provides the randomization sequence using an electronic random number generator (Microsoft Excel Program). Allocation letters are sealed using envelopes in which tranexamic acid or normal saline solutions are provided which look indistinguishable.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapour University of Medical Sciences
Street address
Ethics Committee, It & Research Assistance Center, University complex, Golestan Highway
City
Ahvaz
Postal code
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
IR.AJUMS.REC.1394.153
Health conditions studied
1
Description of health condition studied
Intraoperative Bleeding during Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Estimated amount of intraoperative bleeding
Timepoint
During surgery (starting from the incision till wound closure)
Method of measurement
The volume of blood suctioned during a surgery is calculated by subtracting the amount of irrigation fluid used during a surgery from the total amount of fluid gathered in suction canister at the end of surgery. The volume of blood absorbed by 4*4 inch gauzes during an operation is calculated by multiplying the number of gauzes completely soaked with blood by 10 milliliters (an estimated average of blood absorbed per gauze). These two values are then added to estimate the total intraoperative volume of blood loss.
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention Group 1: Study subjects in the treatment arm will be administered with a bolus intravenous dose of tranexamic acid (10 milligram per kilogram, Caspian – Tamin Pharmaceutical Company, Rasht, Iran) which is transfused slowly after anesthesia induction. Anesthesia is attempted similarly for all patients. Briefly, propofol 2 milligram per kilogram (mg/kg) and fentanyl 1 micro-gram per kilogram are transfused with the aim of induction. Intravenous Atracurium (0.5 mg/kg) is infused to facilitate orotracheal intubation and anesthesia will be maintained using isoflurane inspired at a flow rate of 5 liters per minute in combination with air 30% in oxygen. Intravenous neostigmine 0.04 mg/kg and atropine 0.01 mg/kg will be used to reverse neuromuscular blockage at the end of operation.
Category
Prevention
2
Description
Control Group: Subjects in the control group will receive normal saline as the placebo. Anesthesia is attempted similarly for all patients. Briefly, propofol 2 milligram per kg and fentanyl 1 micro-gram per kilogram are transfused with the aim of induction. Intravenous Atracurium (0.5 mg/kg) is infused to facilitate orotracheal intubation and anesthesia will be maintained using isoflurane inspired at a flow rate of 5 liters per minute in combination with air 30% in oxygen. Intravenous neostigmine 0.04 mg per kg and atropine 0.01 mg per kg will be used to reverse neuromuscular blockage at the end of operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ear Nose and Throat Outpatient Clinic affiliated to Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ghazipoor
Street address
Department of Ear Nose and Throat Surgery, Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Nader Saki, Deputy of research development
Street address
IT & research center, University complex
City
Ahvaz
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 Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Ghazipoor
Position
Associate Professor of Ear Nose and Throat Surgery
Other areas of specialty/work
Street address
Department of Ear Nose and Throat Surgery, Imam Khomeini Hospital, Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61133809012
Fax
Email
Dr.aghp@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Ghazipoor
Position
Associate professor of Ear Nose and Throat Surgery
Other areas of specialty/work
Street address
Department of Ear Nose and Throat Surgery, Imam Khomeini Hospital, Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61133809012
Fax
Email
Dr.aghp@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Ghazipoor
Position
Associate Professor of Ear Nose and Throat Surgery
Other areas of specialty/work
Street address
Department of Ear Nose and Throat Surgery, Imam Khomeini Hospital, Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61133809012
Fax
Email
Dr.aghp@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)