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Comparison of the effect of tranexamic acid and Dexmedetomidine on the amount of bleeding during Spinal posterior fusion surgery

Protocol summary

Study aim
Comparison of the effect of tranexamic acid and dexmedetomidine on the amount of bleeding in posterior spinal fusion surgery
Design
A randomized clinical trial with parallel groups, double-blind, phase 3 on 90 patients. Random allocation of samples to study groups is performed by block randomization method and by using sas 9.4 software.
Settings and conduct
This double-blind clinical trial study will be performed on 90 patients undergoing spinal posterior fusion surgery (in intervention group 1 and intervention 2) in Ayatollah Mousavi Hospital in Zanjan. Random allocation of samples is done by block method and using statistical software. The Boazaart scale will be used to measure the amount of bleeding during the surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-60 years, American Society of Anesthesiologists Class (ASA Class) I & II Exclusion criteria: Drug addiction, Liver and kidney failure, Diabetes, Heart and lung diseases, Coagulation disorders, History of allergies to study drugs, Pregnancy in women, Heart disease includes bradycardia, uncontrolled blood pressure, and AV block II & III, Acute cerebrovascular conditions
Intervention groups
Patients in intervention group 1, before surgery and after induction of anesthesia, receive tranexamic acid (manufactured by Caspian Tamin) with an initial dose of 15 mg/kg for 15 minutes followed by a maintenance intravenous infusion of 1 mg/kg /h. Patients in intervention group 2, before surgery and after induction of anesthesia, receive dexmedetomidine (exir pharmacy) with an initial dose of 1µg/kg for 10 minutes and then with a maintenance intravenous infusion at a dose of 0.7 µg/kg/h.
Main outcome variables
The amount of bleeding during the surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200910048678N2
Registration date: 2021-12-18, 1400/09/27
Registration timing: prospective

Last update: 2021-12-18, 1400/09/27
Update count: 0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
seyede fatemeh gheiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8338
Email address
fatemeh.gheiasi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of tranexamic acid and Dexmedetomidine on the amount of bleeding during Spinal posterior fusion surgery
Public title
Comparison of the effect of tranexamic acid and dexmedetomidine on the amount of bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60 years American Society of Anesthesiologists Class (ASA Class) I & II
Exclusion criteria:
Drug addiction Liver and kidney failure Diabetes Heart and lung diseases Coagulation disorders History of allergies to study drugs Pregnancy in women Heart disease includes bradycardia, uncontrolled blood pressure, and AV block II & III Acute cerebrovascular conditions
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples enter the study in a convenience method. Then, the samples are assigned to two interventions groups 1 and 2 based on random blocks with a size of 4. Random blocks are created based on the PROC PLAN program and in SAS 9.4 software. In order to be able to match samples in terms of age and gender in each group, after the available samples are identified, samples are divided according to age and gender groups and identified in each group. Random allocation will be based on groups. The groups will be divided into two groups based on the cut-off point of 50 years: over 50 years old and under 50 years old, and in terms of gender, they will be divided into two groups, male and female.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients know that they are participating in a study that aims to evaluate the effect of tranexamic acid and dexmedetomidine on reducing intraoperative bleeding but are unaware that they are receiving tranexamic acid and dexmedetomidine. The drugs are similar in color and appearance, prepared in syringes, and coded. The anesthesiologist who injects the drug is not aware of the medication that patients receive.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology, 3th Floor, 2th Bldg., Zanjan University of Medical Sciences, Azadi Blvd. Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.ZUMS.REC.1400.372

Health conditions studied

1

Description of health condition studied
Spinal posterior fusion
ICD-10 code
M43.2
ICD-10 code description
Fusion of spine

Primary outcomes

1

Description
The amount of bleeding
Timepoint
During surgery
Method of measurement
Boezaart scale

Secondary outcomes

empty

Intervention groups

1

Description
Patients in intervention group 2, before surgery and after induction of anesthesia, receive dexmedetomidine (exir pharmacy) with an initial dose of 1µg/kg for 10 minutes and then with a maintenance intravenous infusion at a dose of 0.7 µg/kg/h.
Category
Treatment - Drugs

2

Description
Patients in intervention group 1, before surgery and after induction of anesthesia, receive tranexamic acid (manufactured by Caspian Tamin) with an initial dose of 15 mg/kg for 15 minutes followed by a maintenance intravenous infusion of 1 mg/kg /h.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Mohammad Hossein Brojerdi
Street address
Ayatollah Mousavi Hospital, Gavazang, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Web page address
https://mousavi.zums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Vice-Chancellor for Research and Technology, 3th Floor, 2th Bldg., Zanjan University of Medical Sciences, Azadi Blvd. Zanjan, Iran.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6400
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Hengameh Vaezi
Position
Anesthesia Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavi Hospital, Gavazang, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Hengameh.vaezi88@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Brojerdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavi Hospital, Gavazang, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mhmb20012@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyede Fatemeh Gheiasi
Position
Educational staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Zanjan University of Medical Sciences, Gavazang, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8338
Email
fatemeh.gheiasi@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
Comments
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