Comparison of the Effect of Clonidine and Transxamic Acid on Bleeding During Rhinoplasty Under General Anesthesia
Design
This is a double blind clinical trial with a control group. The groups are divided into two groups (case group 90) and a control group (45 people) in a parallel randomized quadruple randomization method.
Settings and conduct
Preoperative surgery in Khatam Al-anbiya hospital in Shoushtar city will be established for all patients with intravenous tract. In the first group (clonidine group), clonidine 3 micrograms per kilogram will be given orally 90 minutes before surgery. In the second group (the Tranexamic Acid group), the Tranexamic Acid capsule 250 micrograms will be administered orally to patients two hours before the surgery.There will be no intervention in the control group. In this study, the volume of bleeding will be calculated based on the amount of blood collected and the blood-stained gases that will be weighed and the surgeon's vision.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
willingness to participate in research;
aged between 18-60 years;
classification of American Society of Anesthesiology in Class I and II.
Exit criteria:
Drug addiction, benzodiazepines, liver and kidney failure, diabetes, pulmonary and heart disease, coagulation disorders;
history of hypersensitivity to clonidine and tranxacic acid.
Intervention groups
In the first group (Clonidine group), 3 micro grams per kilogram will be given orally 90 minutes before surgery.
In the second group (the Tranexamic Acid group), the 250 mg Tranexamic Acid capsule will be administered orally for patients 2 hours before the surgery.
Main outcome variables
Amount of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121229011923N6
Registration date:2019-02-18, 1397/11/29
Registration timing:prospective
Last update:2019-02-18, 1397/11/29
Update count:0
Registration date
2019-02-18, 1397/11/29
Registrant information
Name
Akram Hematipour
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8302
Email address
hematipour.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Clonidine and Tranexamic Acid on the volume of bleeding during rhinoplasty under general anesthesia: clinical trial
Public title
Comparison of the efficacy of Clonidine and Tranexamic Acid on the volume of bleeding during rhinoplasty under general anesthesia: clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious willingness to participate in research
Age between 18-60 years
Classification of the American Society of Anesthesiology in Class I and II: Class 1: includes patients with normal health who have no systemic problems, such as cardiovascular, respiratory, gastrointestinal, etc. Class 2: Includes a person with mild systemic disease and disease Is under control and has not caused any limitation for the patient)
Exclusion criteria:
Drug addiction, benzodiazepines, liver and kidney failure, diabetes, pulmonary and heart disease, coagulation disorders;
History of hypersensitivity to clonidine and Tranexamic Acid (increased blood pressure)
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
135 people will be selected based on the formula for comparison of the meanings and randomly divided randomly into two groups of case (90) and a control group (45 people) based on the randomized quadruple randomization method. Then, the patients in the case group will be divided into two groups of Clonidine and Tranexamic Acid (45) and (45) by the reviewer, who will code the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients and the ENT surgeon will be unaware of the patient's group and the drugs. Only the investigator responsible for the study who is involved in the classification of the patients is aware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shoushtar University of Medical Sciences
Street address
Shoushtar University of Medical Sciences, West Rajaee Crossroads
City
Shoushtar
Province
Khouzestan
Postal code
6451984381
Approval date
2019-01-14, 1397/10/24
Ethics committee reference number
IR.SHOUSHTAR.REC.1397.007
Health conditions studied
1
Description of health condition studied
Evaluation of bleeding during nasal surgery
ICD-10 code
Y44.2
ICD-10 code description
Anticoagulants
Primary outcomes
1
Description
Evaluation of bleeding during nasal surgery
Timepoint
During and after nose surgery
Method of measurement
The size of the bleeding will be calculated based on the amount of bleeding accumulated in the suction and the blood-stained gases that will be weighed and the surgeon's vision.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: clonidine 3 micrograms per kilogram will be given orally 90 minutes before the surgery, and the amount of bleeding will be examined during surgery.
Category
Treatment - Drugs
2
Description
Second intervention group: Tranexamic Acid capsule 250 micrograms per kilogram body weight will be given to patients twice a day before surgery and the volume of bleeding will be examined during surgery.
Category
Treatment - Drugs
3
Description
Control group: The amount of bleeding will be checked without clonidine and Tranexamic Acid medications.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al-anbia Hospital in Shoushtar
Full name of responsible person
Akram Hemmatipour
Street address
Khatam Al-anbia Hospital, Ammar Street
City
Shoushtar
Province
Khouzestan
Postal code
6451984381
Phone
+98 61 3623 3891
Email
hematipour.a64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shoushtar University of Medical Sciences
Full name of responsible person
Dr Mojtaba Kalantar
Street address
Shoushtar University of Medical Sciences, West Rajaee Crossroads
City
Shoushtar
Province
Khouzestan
Postal code
6451984381
Phone
+98 61 3622 2221
Email
hematipour.a64@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shoushtar 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
Shoushtar University of Medical Sciences
Full name of responsible person
Akram Hemmatipour
Position
University professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shoushtar University of Medical Sciences, West Rajaee Crossroads
City
Shoushtar
Province
Khouzestan
Postal code
6451984381
Phone
+98 61 3622 2221
Email
hematipour.a64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shoushtar University of Medical Sciences
Full name of responsible person
Akram Hemmatipour
Position
University professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shoushtar University of Medical Sciences, West Rajaee Crossroads
City
Shoushtar
Province
Khouzestan
Postal code
6451984381
Phone
+98 61 3622 2221
Email
hematipour.a64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shoushtar University of Medical Sciences
Full name of responsible person
Akram Hemmatipour
Position
University professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shoushtar University of Medical Sciences, West Rajaee Crossroads
City
Shoushtar
Province
Khouzestan
Postal code
6451984381
Phone
+98 61 3622 2221
Email
hematipour.a64@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
I do not know
When the data will become available and for how long
I do not know
To whom data/document is available
I do not know
Under which criteria data/document could be used
I do not know
From where data/document is obtainable
I do not know
What processes are involved for a request to access data/document