Comparing the preventive effects of tranexamic acid, dexmedetomidine and nitroglycerin on bleeding rate and visual field during septorinoplasty
Design
In this double-blind clinical trial study (participants and results analyzer), patients will undergo surgery after random allocation in the three mentioned groups. For one group, the drug dexmedetomidine will be injected intravenously, for the other group, the drug nitroglycerin, and for the third group, the drug tranexamic acid will be injected intravenously, the bleeding during surgery will be compared between the three groups.
Settings and conduct
This study will be conducted in the operating room of Imam Reza Hospital (Medical Sciences, Tabriz) with the participation of 90 patients who are candidates for septorhinoplasty surgery and in a double-blind manner (participants and results analyzer).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Septorhinoplasty candidate, in the age range of 18 to 60 years, class I or II according to ASA and appropriate control of blood pressure; Exclusion criteria: sensitivity to the study drugs, the need to prescribe blood pressure stimulants in addition to the drugs prescribed in each group.
Intervention groups
In this study, patients who will refer to the operating room due to septorhinoplasty surgery will be subjected to intervention. Intervention group 1: receiving intravenous tranexamic acid; Intervention group 2: receiving intravenous dexmedetomidine and intervention group 3: receiving intravenous nitroglycerin and finally the amount of bleeding will be measured in them.
Main outcome variables
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N47
Registration date:2024-05-03, 1403/02/14
Registration timing:prospective
Last update:2024-05-03, 1403/02/14
Update count:0
Registration date
2024-05-03, 1403/02/14
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-18, 1403/03/29
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the preventive effects of tranexamic acid, dexmedetomidine and nitroglycerin on bleeding rate and visual field during septorinoplasty
Public title
Comparison of the effects of three different drugs on the amount of bleeding and visual field during septorhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Septorhinoplasty candidate
In the age range of 18 to 60 years
ASA class I or II
Proper control of blood pressure
Exclusion criteria:
Allergy to study drugs
The need to prescribe blood pressure stimulating drugs in addition to the drugs prescribed in each group.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 90, we use the patients using the block permutation randomization method, which is used in this method in order to balance the number of allocated samples, and with 4 people in each block, the entire block We put the possible ones as follows. block 1:BBAA and block 2:AABB and block 3:ABAB and block 4:BABA and block 5:ABBA and block6:BAAB we need 23 blocks for 90 people. It is in the block method, we choose from numbers one to six, for example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they will be divided into three intervention groups (group A), the second intervention group (group B) and the control group (group C).
Blinding (investigator's opinion)
Double blinded
Blinding description
The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of drug used, in this study they will not know what type of drug will be used in other patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2023-08-27, 1402/06/05
Ethics committee reference number
IR.TBZMED.REC.1402.389
Health conditions studied
1
Description of health condition studied
Bleeding
ICD-10 code
D78.2
ICD-10 code description
Postprocedural hemorrhage and hematoma of the spleen following a procedure
Primary outcomes
1
Description
Bleeding
Timepoint
At the end of the surgery
Method of measurement
By measuring the amount of blood in the suction
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The dexmedetomidine group will receive this drug at the rate of 1 microgram/kg intravenously within 15 minutes at the beginning of the surgery, and the amount of bleeding will be measured at the end of the study.
Category
Treatment - Drugs
2
Description
Intervention group:The tranexamic acid group will receive this drug at the rate of 10 mg/kg tranexamic acid intravenously within 15 minutes at the beginning of the surgery, and the amount of bleeding will be measured at the end of the study.
Category
Treatment - Drugs
3
Description
Control group: The nitroglycerin group will receive this drug at the rate of 0.5 mg/kg intravenously within 15 minutes at the beginning of the surgery, and the amount of bleeding will be measured at the end of the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Marjan Dehdilani
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available