Determining the comparison of the local effect of tranexamic acid and phenylephrine on the rate of bleeding in rhinoplasty in patients undergoing rhinoplasty in Shahid Ayatollah Dastgheib Hospital in Shiraz, 2019-2020
Design
study was performe on 98 patients in Ayatollah Dastgheib Hospital on rhinoplasty candidates who were randomly admitted to the study. Randomization is performed in a one-to-one ratio between the two groups in variable block sizes. The subjects were divided into two study groups. Website address: https://www.randomizer.org/
Settings and conduct
This study was performed on 98 patients in Dastgheib Hospital in Shiraz who in two intervention groups poured 1 cc of phenylephrine and tranexamic acid on the mesh and packed for five minutes immediately after intubation and before making a surgical incision inside the nasal cavity.
Participants/Inclusion and exclusion criteria
Entry requirements: Candidate patients for rhinoplasty، willingness to participate in the intervention
full consciousness، age 20-30 years
Exit conditions: Sensitivity known to tranexamic acid and phenylephrine
Tachycardia and high blood pressure140/90
History of coagulation disorder, warfarin use.
Intervention groups
Intervention group with 1 cc of phenylephrine (Phenylephrine Hcl, Nasal Drop, 0.5%) which is poured on the mesh and packed for five minutes immediately after intubation and before making a surgical incision inside the nasal cavity.
In the second group, 1 cc of tranexamic acid (Solution 500mg / 5ml) is used in the same way.
Main outcome variables
Blood pressure,tachycardia,bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201205049602N1
Registration date:2021-04-24, 1400/02/04
Registration timing:retrospective
Last update:2021-04-24, 1400/02/04
Update count:0
Registration date
2021-04-24, 1400/02/04
Registrant information
Name
Negar Shahkarami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3222 0639
Email address
negar.shahkarami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-06, 1399/09/16
Expected recruitment end date
2021-01-05, 1399/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of local effect of tranexamic acid and phenylephrine on bleeding rate in rhinoplasty
Public title
Comparison of the effect of tranexamic acid and phenylephrine on bleeding rate in rhinoplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for rhinoplasty
willingness to participate in the intervention
full consciousness
age 20-30 years
Exclusion criteria:
Sensitivity known to tranexamic acid and phenylephrine
Tachycardia and high blood pressure140/90
History of coagulation disorder, warfarin use
Sensitivity known to tranexamic acid
high blood pressure140/90
History of warfarin use
Age
From 20 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are assigned a login number in the order they enter. This number is also used for all their data collection forms. The randomization sequence is generated by an epidemiologist based on rendomizer software. Randomization is first divided into two categories based on the name of the surgeon (two surgeons). Then, in each of these two classes, randomization is performed in a one-to-one ratio in variable block sizes (multiples of 2). Based on this, people are assigned to one of the two groups studied. The numbers are based on the order in which people enter the study. From 1 to 98.These numbers are written on the back of the envelopes and inside the code envelope specified by the randomizer software. In order, after entering each person with the eligibility criteria, the first envelope is opened and based on the specified code, the drug with the same code written on the label is injected into the person.
Website address of rendomizer software:https://www.randomizer.org/
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is anesthetized and is not aware of his affiliation with any of the study groups. Mesh preparation with phenylephrine and tranexamic acid content is performed by an independent colleague and the physician and the outcome assessor are not aware of the assignment of the subjects to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Farah abad,Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
7195865364
Approval date
2020-08-11, 1399/05/21
Ethics committee reference number
IR.MAZUMS.REC.1399.518
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
Timepoint
Before the intervention, 5, 15 and 30 minutes after the intervention
Method of measurement
Calculation of the amount of blood in the suction and the surgeon's satisfaction with the surgical field
2
Description
Tachycardia
Timepoint
Before the intervention, 5, 15 and 30 minutes after the intervention
Method of measurement
Using patient vital signs monitoring
3
Description
blood pressure
Timepoint
Before the intervention, 5, 15 and 30 minutes after the intervention
Method of measurement
Using patient vital signs monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, 1 cc of phenylephrine (Phenylephrine Hcl, Nasal Drop, 0.5%) is drawn with a syringe and poured on the mesh and packed for five minutes immediately after intubation and before making a surgical incision inside the nasal cavity.
Category
Prevention
2
Description
Intervention group: In the second group, 1 cc of solution for injection Tranexamic Acid, Injection Solution 500mg / 5ml),) with a syringe and poured on the mesh and packed for five minutes immediately after intubation and before making a surgical incision inside the nasal cavity Be
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ayatollah Dastgheib Hospital in Shiraz
Full name of responsible person
Hooshang Akbari
Street address
Hafez Ave
City
Shiraz
Province
Fars
Postal code
7195865364
Phone
+98 71 3222 0630
Email
negar.shahkarami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majeed saeedi
Street address
NO. 140, Amir Mazandarani Ave, Keshavarz Blv
City
Sari
Province
Mazandaran
Postal code
719565364
Phone
+98 71 3222 0639
Email
negar.shahkarami@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Negar shahkarmi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
NO, 12. Mirza Hafez Ave
City
SHiraz
Province
Fars
Postal code
7195865364
Phone
+98 71 3222 0639
Email
negar.shahkarami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hooshang Akbari
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Farah Abad Ave, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
8137946855
Phone
+98 11 3304 4000
Email
hooshangakbari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Negar shahkarami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No,12. Mirza Hafez Ave
City
Shiraz
Province
Fars
Postal code
715865364
Phone
+98 71 3222 0639
Email
negar.shahkarami@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available