Comparison of the effect of two doses of tranexamic acid on intraoperative hemodynamic changes in patients undergoing adenotonsillectomy
Design
A clinical trial without a parallel control group, double-blind, randomized
Settings and conduct
This study is performed at Imam Hossein Children's Hospital.
After premedication, patients with midazolam 0.1 mg / kg are separated from their parents and brought to the operating room. They were then anesthetized with 2μg / kg fentanyl, 5mg / kg thiopental sodium and 0.5mg / kg atracurium, intubated with the appropriate size, attached to the ventilator, and anesthetized with 1% isoflurane. Patients were then randomly divided into two groups of 32 according to the random number table. One group received 5mg / kg tranexamic acid for 10 minutes and another group received 10mg / kg tranexamic acid for 10 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 5 to 10 years are candidates for ASAI, ASAI adenotonsillectomy; Exclusion criteria: any underlying disease, bleeding disorders, impaired coagulation tests (PT, PTT, INR) and metabolic disorders.
Intervention groups
The first group received 5mg / kg tranexamic acid and the second group received 10mg / kg tranexamic acid.
Main outcome variables
Mean arterial pressure; Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N33
Registration date:2020-03-27, 1399/01/08
Registration timing:prospective
Last update:2020-03-27, 1399/01/08
Update count:0
Registration date
2020-03-27, 1399/01/08
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2021-03-25, 1400/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of two doses of tranexamic acid on intraoperative hemodynamic changes in patients undergoing adenotonsillectomy
Public title
Comparison of the effect of two doses of tranexamic acid on hemodynamic changes in patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 5 to 10 years are candidates for ASAI, ASAI adenotonsillectomy.
Exclusion criteria:
The patient has any underlying disease
The patient has bleeding disorders
Patient with coagulation disorders (PT, PTT, INR)
The patient has metabolic disorders
Age
From 5 years old to 10 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample was simple randomly divided into two groups of 32 people, each by selective envelopes. Thus, each envelope containing one of the two A and B labels represented one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding method is that the drugs are drawn and coded by the researcher in equal volumes on the same syringes. The prescribing anesthetist and the nurse recorder are not aware of the patients' placement in the groups.
Placebo
Not 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
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.MUI.MED.REC.1398.639
Health conditions studied
1
Description of health condition studied
Hemodynamic changes
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis
Primary outcomes
1
Description
Mean arterial pressure
Timepoint
Before induction and during anesthesia every 15 minutes
Method of measurement
Mercury barometer
2
Description
Pulse rate
Timepoint
Before induction and during anesthesia every 15 minutes
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: First group receive 5mg / kg tranexamic acid from Caspian Pharmaceutical Company intravenously and slowly once during 10 minutes before surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2: Second group receive 10 mg / kg tranexamic acid from Caspian Pharmaceutical Company intravenously and slowly once during 10 minutes before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
In Imam Hossein Pediatric Hospital, Isfahan
Full name of responsible person
Amir Shafa
Street address
Imam Hossein Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
amir_shafa@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sh_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
Amir Shafa
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
amir_shafa@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
amir_shafa@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
amir_shafa@med.mui.ac.ir
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