Investigating the effect of subcutaneous tranexamic acid injection on the amount of bleeding in rhinoplasty surgery under general anesthesia.
Design
A clinical trial with a control group, phase 2-3 on 60 patients to investigate the amount of bleeding during rhinoplasty with and without tranexamic acid injection.
Settings and conduct
This study is conducted in 2022 at Al-Zahra Hospital in Isfahan on 60 patients who are candidates for rhinoplasty surgery. Within 60 minutes from the start of surgery and every 10 minutes during the first 20 minutes of recovery, the amount of bleeding in the two groups of patients is measured and compared by a suction device.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18–50 years, candidate for rhinoplasty, having a score of 1 or 2 according to the American Society of Anesthesiologists and signing a written informed consent to participate in this study.
Exclusion criteria: uncontrolled systemic disease, history of malignant hyperthermia, refusal to continue participating in the study and occurrence of any complications during surgery.
Intervention groups
Intervention group: Patients in this group, during anesthesia, receive 10 cc of a solution that contains 5 cc of a solution containing half percent lidocaine and epinephrine (1 in four hundred thousand) and 5 cc of 10 percent tranexamic acid. Control group: Patients in this group, during anesthesia, receive 10 cc of a solution containing half percent lidocaine and epinephrine (one in two hundred thousand). The bleeding rate of patients is measured and compared at the end of surgery.
Main outcome variables
Bleeding.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N14
Registration date:2022-09-28, 1401/07/06
Registration timing:prospective
Last update:2022-09-28, 1401/07/06
Update count:0
Registration date
2022-09-28, 1401/07/06
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-05, 1401/08/14
Expected recruitment end date
2023-01-04, 1401/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of subcutaneous tranexamic acid injection on the amount of bleeding in rhinoplasty surgery under general anesthesia.
Public title
Tranexamic acid on bleeding rate in rhinoplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years
Candidate for rhinoplasty
Having a score of 1 or 2 based on the American Society of Anesthesiologists
Signing the written informed consent to participate in this study
Exclusion criteria:
Uncontrolled systemic disease
History of malignant hyperthermia
Refusing to continue participating in the study
Incidence of any complication during surgery
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-12-24, 1400/10/03
Ethics committee reference number
IR.MUI.MED.REC.1400.709
Health conditions studied
1
Description of health condition studied
Bleeding
ICD-10 code
D78.22
ICD-10 code description
Postprocedural hemorrhage and hematoma of the spleen following other procedure
Primary outcomes
1
Description
Bleeding volume
Timepoint
Within 60 minutes from the start of surgery and every 10 minutes during the first twenty minutes of recovery
Method of measurement
Suction device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group, during anesthesia, receive 10 cc of a solution that contains 5 cc of a solution containing half percent lidocaine and epinephrine (1 in four hundred thousand) and 5 cc of 10 percent tranexamic acid. The bleeding rate of patients is measured and compared at the end of surgery.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group, during anesthesia, receive 10 cc of a solution containing half percent lidocaine and epinephrine (one in two hundred thousand). The bleeding rate of patients is measured and compared at the end of surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Hamid Shetabi
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Send a message to the mentioned e-mail address
What processes are involved for a request to access data/document
E-mail the responsible person and if you accept the conditions, the information will be sent.