Comparison of the effect of tranexamic acid and remifentanil on intraoperative hemorrhage in dacryocystorhinostomy and comparing with control group
Design
This study is a double-blind randomized clinical trial study with parallel groups. 165 patients undergoing dacryocystorhinostomy surgery will be divided into three groups with using Random Allocation Software. The groups were included intervention group 1 (receiving bolus of tranexamic acid 15 mg / kg in a 15-minute period with 500 ml of normal saline), intervention group 2 (receiving remifentanil infusion of 0.1 to 0.3 μg / kg / min until the end of surgery), group 3 (placebo).
Settings and conduct
This study was carried out in Feyz hospital in Isfahan during 2018 to 2020. A total of 165 patients undergoing DCR surgery are enrolled in the study according to inclusion and exclusion criteria and are divided into three groups of tranexamic acid and remifentanil and control by random allocation software. Patients, drug prescriber, data collector, and data analyzer were not aware of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for classic dacryocystorhinostomy surgery, age range between 18 and 75 years, no sensitivity to drugs, no coagulation problems, no addiction, no chronic underlying disease
Exclusion criteria: Changing the anesthesia procedure
Intervention groups
Intervention group 1: receiving bolus of tranexamic acid 15 mg / kg in a 15-minute period with 500 ml of normal saline, intervention group 2: receiving remifentanil infusion of 0.1 to 0.3 μg / kg / min until the end of surgery, group 3: placebo.
Main outcome variables
Intraoperative bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N42
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-16, 1398/04/25
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of tranexamic acid and remifentanil on intraoperative hemorrhage in dacryocystorhinostomy and comparing with control group
Public title
Effect of tranexamic acid and remifentanil on intraoperative hemorrhage in dacryocystorhinostomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for classic dacryocystorhinostomy surgery
Age range between 18 and 75 years
No sensitivity to drugs
No coagulation problems
No addiction
No chronic underlying disease
Exclusion criteria:
Changing the anesthesia procedure
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 165 patients undergoing DCR surgery are enrolled in the study according to inclusion and exclusion criteria and are divided into three groups of tranexamic acid and remifentanil and control by random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are anesthetized and have no knowledge of the treatment group, and the drug is injected by an anesthesiologist who is blinded of the treatment and is not involved in the measurements. Measurements are performed by the project manager who is aware of the grouping. The information is coded into the software and the analyzer is unaware of the group assignment. After the design and analysis of the data, the codes are opened.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.MUI.MED.REC.1398.197
Health conditions studied
1
Description of health condition studied
dacryocystorhinostomy
ICD-10 code
H04.549
ICD-10 code description
Stenosis of unspecified lacrimal canaliculi
Primary outcomes
1
Description
Intraoperative bleeding
Timepoint
From the beginning of the operation to the end of the operation
Method of measurement
The volume of blood suctioned per ml
Secondary outcomes
1
Description
Hemodynamic Disorder
Timepoint
Every 15 minutes during operation and recovery
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Intervention group: receiving bolus of tranexamic acid 15 mg / kg in a 15-minute period with 500 ml of normal saline
Category
Prevention
2
Description
Intervention group: receiving remifentanil infusion of 0.1 to 0.3 μg / kg / min until the end of surgery
Category
Prevention
3
Description
Control group: receiving placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Kamran Montazeri
Street address
Modarres Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
montazeri@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayesh Haghjoo
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Kamran Montazeri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
montazeri@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kamran Montazeri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
montazeri@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
al.mehrabi@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
Information belongs to government agency
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Because the information belongs to a government agency, it cannot be shared.
When the data will become available and for how long
Any time
To whom data/document is available
Any person
Under which criteria data/document could be used
Under any circumstances
From where data/document is obtainable
Any person, any time
What processes are involved for a request to access data/document