Comparison of the effect of tranexamic acid and intravenous desmopressin on reducing bleeding during septorhinoplasty.
Design
This study is a randomized, double-blind, phase 3 clinical trial with a sample size of 175 patients randomly assigned to three groups.
The first group receives tranexamic acid.
The second group received desmopressin.
And the third group is given placebo
Settings and conduct
n this study, 177 patients undergoing septorhinoplasty will be divided into three groups including intravenous tranexamic acid, intravenous desmopressin and placebo. All patients will receive the same premedication and all patients will receive propofol during surgery. and remifentanil is given during the operation depend on the blood pressure and heart rate and if the blood pressure is not controlled, propofol will increase and then Depending on the heart rate and blood pressure, TNG and labetalol will be used.
The amount of bleeding is determined by the volume of the suction and the amount of blood in the gases. Surgeons' satisfaction from the operating field is measured by a questionnaire. The PT, PTT, INR and platelet counts were compared before and after the surgery. This study was performed at Rasool Akram Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Perform Septorhinoplasty
No coagulation disorders
18 Years until 50 Years
ASA-1
Intervention groups
In the first intervention group, Tranexamic acid was injected half an hour before surgery at a dose of 5 mg / kg.
And in the second intervention group Desmopressin injected at 4 μg / ml half an hour before surgery
And in the control group the same amount of placebo is given with similar characteristics.
Main outcome variables
Age
Gender
Suction volume
Number of gases
PT
PTT
INR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200124046241N1
Registration date:2020-03-01, 1398/12/11
Registration timing:retrospective
Last update:2020-03-01, 1398/12/11
Update count:0
Registration date
2020-03-01, 1398/12/11
Registrant information
Name
Taimaz Amiraslani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2278 5427
Email address
golezard1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2019-08-23, 1398/06/01
Trial completion date
2019-08-23, 1398/06/01
Scientific title
Comparison of the effect of tranexamic acid and intravenous desmopressin on reducing bleeding during septorhinoplasty.
Public title
Comparison of the effect of tranexamic acid and intravenous desmopressin on reducing bleeding during septorhinoplasty.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Perform septorhinoplasty
No coagulation disorders
18 Years until 50 Years
ASA-1
Exclusion criteria:
Contraindications for the administration of Tranexamic acid and Desmopressin
Dissatisfaction with research
Drug addiction
Being a smoker
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
175
Actual sample size reached:
175
Randomization (investigator's opinion)
Randomized
Randomization description
This study was designed as a clinical trial in which the number of patients was determined according to the sample size formula and the patients were randomly selected using a simple randomization method that provided a data code to each patient using a random number table. By random selection of the code, patients were assigned to three treatment groups without observing the patients' codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is unaware of the process of prescribing medications and control groups, as well as those who provide care and treatment to the patients participating in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 16, Karimi Ave., Yarmohammadi Ave., Daroos Ave., Pasdaran Town
City
Tehran
Province
Tehran
Postal code
1944644651
Approval date
2018-04-04, 1397/01/15
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511174002
Health conditions studied
1
Description of health condition studied
Septorhinoplasty
ICD-10 code
B46.1
ICD-10 code description
Rhinocerebral mucormycosis
Primary outcomes
1
Description
Bleeding
Timepoint
During surgery
Method of measurement
The amount of bleeding is determined by the volume of the suction and the number of blood gases.
Secondary outcomes
1
Description
Blood pressure
Timepoint
During surgery
Method of measurement
With barometer
2
Description
Heart rate
Timepoint
During surgery
Method of measurement
Pulse Oximeter
Intervention groups
1
Description
Intervention group: Intravenous tranexamic acid, produced by Caspian Drug Co., 500 mg / 5 ml, half an hour before surgery, 5 mg / kg, intravenously.
Category
Treatment - Drugs
2
Description
Intervention group: Desmopressin is an injection produced by the Razavi Pharmaceutical Services Institute, which is administered intravenously at a dose of 4 μg / ml once a half hour before surgery.
Category
Treatment - Drugs
3
Description
Control group: Placebo is similar to both transaminic acid and desmopressin from distilled water and used intravenously half an hour before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
Taimaz Amiraslani
Street address
No. 16, Karimi Ave., Yarmohammadi Ave., Daroos Ave., Pasdaran Town
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 2278 5427
Email
Golezard1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Taimaz Amiraslani
Street address
No. 16, Karimi Ave., Yarmohammadi Ave., Daroos Ave., Pasdaran Town
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 2278 5427
Email
Golezard1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Taimaz Amiraslani
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 16, Karimi Ave., Yarmohammadi Ave., Daroos Ave., Pasdaran Town