Comparative study of the effects of clonidine and tranexamic acid on the rate of bleeding during rhinoplasty surgery
Design
This study is a randomized double-blind clinical trial with a parallel design. This randomized study will be conducted on 92 patients who are candidates for rhinoplasty surgery. A simple random method is used for randomization and the participants are assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at Imam Reza Hospital in Kermanshah, is double-blind. The outcome assessor and the participants are blinded to the study group allocation. Before surgery, venous access is established for all patients, and routine monitoring of the operating room, including non-invasive blood pressure measurement, ECG monitoring, and pulse oximetry, is performed by the anesthesia team.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Age between 18-60 years
Exclusion criteria: Addiction to narcotics and benzodiazepines
History of seizures; Suffering from liver and kidney failure, diabetes, lung and heart diseases, and coagulation disorders; History of allergy to clonidine and tranexamic acid drugs
Intervention groups
The first intervention group will receive 700 micrograms of tranexamic acid per kilogram of body weight orally two hours before surgery. The second intervention group will receive 2 micrograms of clonidine per kilogram orally 90 minutes before surgery.
Main outcome variables
Bleeding rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N211
Registration date:2023-11-25, 1402/09/04
Registration timing:prospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effects of clonidine and tranexamic acid on the rate of bleeding during rhinoplasty surgery. Clinical trial
Public title
Comparison of the effects of clonidine and tranexamic acid on the rate of bleeding during nose surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Age between 18-60 years
Exclusion criteria:
Addiction to narcotics and benzodiazepines
History of seizures
Suffering from liver and kidney failure, diabetes, lung and heart diseases, coagulation disorders
History of allergy to clonidine and tranexamic acid drugs
pregnancy
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible patients, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned in the first intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the second intervention group
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, the patients are aware of their participation in the study and receiving the medication, but the outcome evaluator is blinded to the allocation of the study groups and the medication they received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-09-03, 1402/06/12
Ethics committee reference number
IR.KUMS.MED.REC.1402.172
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
M95.0
ICD-10 code description
Acquired deformity of nose
Primary outcomes
1
Description
Bleeding rate
Timepoint
The beginning of the study and the end of the study
Method of measurement
Based on the amount of blood collected in the suction
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 700 micrograms of tranexamic acid per kilogram of body weight orally two hours before surgery
Category
Treatment - Drugs
2
Description
The second intervention group will receive 2 micrograms of clonidine per kilogram orally 90 minutes before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Maryam safdari
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sainasfd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam safdari
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Emam Reza Hospital, Parastar Boulevard
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sainasfd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Bagher Heydari
Position
Member of the academic staff of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Plastic Surgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sainasfd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Safdari
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sainasfd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD