Comparison of Tranexamic acid, Remifentanil, and Hydralazine on the bleeding volume during Dacryocystorhinostomy
Design
Phase 2-3 clinical trial without control group is performed on 90 patients with 2-in-2 factorial groups to evaluate tranexamic acid, remifentanil and hydralazine on bleeding volume.
Settings and conduct
This study is performed in Feyz Hospital in Isfahan. Patients will be treated with anti-bleeding methods in three ways. The first group receives remifanthanil, the second group receives hydralazine and the third group receives tranexamic acid. This study is not blind. After treatment, the patients' bleeding rate will be evaluated and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 and 80 years, candidate for dacryocystorhinostomy, and having a score of 1 or 2 based on the American Society of Anesthesiologists
Exclusion criteria: uncontrolled systemic disease, history of malignant hyperthermia, refusal to participate in the study, and occurrence of any complication during surgery
Intervention groups
Intervention group 1: Patients in this group, ten minutes before the start of surgeries, receive remifentanil made by Abu Reihan Company at a dose of 0.1 micrograms per kilogram and injected.
Intervention procedure 2: Patients in this group, ten minutes before the start of surgeries, receive a hydralazine drug made by Abu Reihan Company at a dose of 0.1 mg per kg and by injection.
Intervention group 3: Patients in this group, ten minutes before the start of surgeries, receive a transexamic acid drug made by Abu Reihan Company at a dose of 10 mg per kg and by injection.
The amount of bleeding in patients at the end of surgery is measured by examining the blood in the suction.
Main outcome variables
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N10
Registration date:2022-04-11, 1401/01/22
Registration timing:retrospective
Last update:2022-04-11, 1401/01/22
Update count:0
Registration date
2022-04-11, 1401/01/22
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
2019-07-21, 1398/04/30
Expected recruitment end date
2019-12-20, 1398/09/29
Actual recruitment start date
2019-07-21, 1398/04/30
Actual recruitment end date
2019-12-20, 1398/09/29
Trial completion date
2020-12-19, 1399/09/29
Scientific title
Comparison of Tranexamic acid, Remifentanil, and Hydralazine on the bleeding volume during Dacryocystorhinostomy
Public title
Tranexamic acid, Remifentanil, and Hydralazine and the bleeding volume
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 80 years
Being a candidate for Dacryocystorhinostomy
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 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
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
2019-03-17, 1397/12/26
Ethics committee reference number
IR.MUI.MED.REC.1397.373
Health conditions studied
1
Description of health condition studied
Dacryocystitis
ICD-10 code
H04.30
ICD-10 code description
Unspecified dacryocystitis
Primary outcomes
1
Description
Bleeding
Timepoint
End of surgery
Method of measurement
Measuring the blood collected in the suction bottle at the end of surgery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Candidate patients for dacryocystorhinostomy surgery In this group, ten minutes before the start of surgery, remifentanil made by Abu Reihan company is injected at a dose of 0.1 micrograms per injection. The amount of results at the end of surgery is measured by examining the blood in suction.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients who are candidates for dacryocystorhinostomy surgery in this group, ten minutes before the start of surgeries, receive a hydralazine drug made by Abu Reihan Company at a dose of 0.1 mg per kg and by injection. The amount of bleeding in patients at the end of surgery is measured by examining the blood in the suction.
Category
Treatment - Drugs
3
Description
Intervention group 3: Patients who are candidates for dacryocystorhinostomy surgery in this group, ten minutes before the start of surgeries, receive a transexamic acid drug made by Abu Reihan Company at a dose of 10 mg per kg and by injection. The amount of bleeding in patients at the end of surgery is measured by examining the blood in the suction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz hospital
Full name of responsible person
Darioush Moradi Farsani
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
Darioush Moradi Farsani
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@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
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.