Reducing bleeding in nasal surgery and increasing surgeon satisfaction
Design
The current clinical trial without a control group, with parallel groups, double-blind, is on 105 patients, which is done by the block method and using Excel.
Settings and conduct
This study is carried out in the operating room of Ba'ath Hospital in Hamedan. In this study, a combination of dexmethomadine and tranexamic acid is injected to patients to prevent nose surgery bleeding. In this study, in order to make the study double-blind, the drugs are prepared in advance by the researcher and provided to the clinical caregiver. And the evaluator is not aware of the patient classification.
Participants/Inclusion and exclusion criteria
Candidates for rhinoplasty surgery whose hemoglobin is more than 10 and whose age is more than 18 years old can enter the study. Patients with a history of heart disease, seizures and chronic hypertension cannot participate in this study.
Intervention groups
Patients who are candidates for rhinoplasty surgery receive a group of tranexamic acid drugs to prevent bleeding during surgery. The second group receives the drug dexmethomidine to prevent surgical bleeding, and the third group receives the combination of two drugs, tranexamic acid and dexmethomidine.
Main outcome variables
In this study, bleeding during surgery and surgeon satisfaction during surgery are examined
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230816059159N1
Registration date:2023-10-01, 1402/07/09
Registration timing:registered_while_recruiting
Last update:2023-10-01, 1402/07/09
Update count:0
Registration date
2023-10-01, 1402/07/09
Registrant information
Name
Ibrahim KariIm
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1014
Email address
ebrahimhadad5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the combined effect of dexmedetomidine and tranexamic acid on bleeding and surgeon satisfaction in nasal surgery.
Public title
combined effect of dexmedetomidine and tranexamic acid in nasal surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a candidate for nasal surgery
The patient must be at least 18 years old
The patient has informed consent
Exclusion criteria:
The patient has a history of heart disease
The patient has a history of seizures
The patient has a history of hypertension
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The people under study will be assigned to three intervention groups using the random number generation software. In this way, first, a random table is designed using Microsoft Excel software for the number of samples (102 samples). Numbers 1 to 34 are assigned to the tranexamic acid group, numbers 35 to 68 to the dexmethomedin group, and numbers 69 to 102 to the combined group. Patients are divided into groups in the order they enter the study using a random table. study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are prepared in uniform syringes by the researcher and provided to the clinical caregiver. The clinical caregiver does not know which patient is receiving which drug. The evaluator also does not know which insurance company received which medicine.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh St, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838765
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.UMSHA.REC.1402.383
Health conditions studied
1
Description of health condition studied
Bleeding rate in nasal candidate patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
surgery bleeding
Timepoint
Bleeding measurement time: before drug injection, after drug injection every 15 minutes until the end of surgery
Method of measurement
Volume of blood suctioned in cubic centimeters
2
Description
surgeon satisfaction
Timepoint
before drug injection, after drug injection every 15 minutes until the end of surgery
Method of measurement
The surgeon's satisfaction is evaluated based on a four-point classification
Secondary outcomes
1
Description
The patient's blood pressure
Timepoint
Every 15 minutes after drug injection until the end of surgery
Method of measurement
sphygmomanometer
Intervention groups
1
Description
Combined injection of dexmethomadine (Made by Arang drug therapy Pharmaceutical Company) and ternaxamic acid (Made by Caspian Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery. after the start of general anesthesia, tranexamic acid will prescribe at a dose of 10 mg per kilogram of body weight at a rate of 100 mg per minute. prevention of bleeding in patients who are candidates for nose surgery, dexmedetomidine will prescribe 0.1 micrograms per kilogram of body weight within 10 minutes and then 0.5 micrograms per kilogram of body weight is prescribed within an hour. These drugs are prescribed intravenously.
Category
Prevention
2
Description
Injection of dexmedetomidine (Made by Arang drug therapy Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery, dexmedetomidine will prescribe 0.1 micrograms per kilogram of body weight within 10 minutes and then 0.5 micrograms per kilogram of body weight is prescribed within an hour. and during the surgery, this drug is injected intravenously. the patient's bleeding rate and the surgeon's satisfaction are checked.
Category
Prevention
3
Description
Injection of ternaxamic acid (Made by Caspian Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery. At the beginning of the surgery, this drug is injected intravenously to the patient in one step, after the start of general anesthesia, tranexamic acid will prescribe at a dose of 10 mg per kilogram of body weight at a rate of 100 mg per minute. and during the surgery, the patient's bleeding rate and the surgeon's satisfaction are checked.
Hamedan University of Medical Sciences, Shahid Fahmideh St
City
Hamedan
Province
East Azarbaijan
Postal code
6517838756
Phone
+98 81 3838 1014
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
40
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
Hamedan University of Medical Sciences
Full name of responsible person
Behroz Karkhanei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Fahmida St, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838667
Phone
008138381014
Email
bk13472000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behroz Karkhanei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Fahmida St, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838765
Phone
+98 81 3838 1014
Email
bk13472000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ebrahim Karim
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Fahmideh, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838765
Phone
+98 81 3838 1014
Fax
Email
ebrahimhadad5@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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
This information is made available after de-identifying individuals and includes information that reports the main outcomes of the plan.
When the data will become available and for how long
Access starts from 2031
To whom data/document is available
The access of anesthesia department instructors is allowed
Under which criteria data/document could be used
The use of data in the way of patient control is unimpeded, its use in the context of review studies is allowed. The data can be used in review studies. In this field, university professors and educational researchers can receive documents by presenting them.
From where data/document is obtainable
You can access the data by referring to Hamedan University of Medical Sciences, Faculty of Paramedicine, Department of Intelligence, Room 4 or by sending an email to the mentioned address.
bk13472000@yahoo.com
What processes are involved for a request to access data/document
By sending an email to Behrouz karkhanei and stating the reason for the request, he can use or access the data with an acceptable and effective reason for the education and care of patients.