comparison of the hemodynamic changes following tourniquet use in orthopedic surgeries in two different age groups
Design
This interventional study has a control group, with parallel groups, double-blind, randomized, on 130 patients. The method of random allocation will be with the help of a table of random numbers.
Settings and conduct
After the patient enters the operating room of Shahada Hospital of Tabriz and performs routine monitoring of the department, all patients will be put under the same general anesthesia. The desired variables will be investigated in one group with routine tourniquet pressure in people over 65 years old and under 65 years old and in the other group with modified tourniquet pressure based on systolic pressure in people over 65 years old and under 65 years old. The filling of the questionnaire is done by someone who does not know the amount of pressure inside the tourniquet. The surgeon will not know the amount of tourniquet pressure. A standard calibrated tourniquet will be used in all surgeries.
Participants/Inclusion and exclusion criteria
1. All patients over 18 years of age who have an indication for upper or lower limb orthopedic surgery with the possibility of using a tourniquet. 2. Have consent to study.
Intervention groups
SBP+100-130 in the lower limb and SBP+50-70 in the upper limb
Main outcome variables
Stability of the patient's hemodynamic status during surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240315061297N1
Registration date:2024-07-11, 1403/04/21
Registration timing:retrospective
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Mohammad Reza Bazavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3389 3765
Email address
mrbazavar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the hemodynamic changes following tourniquet use in orthopedic surgeries in two different age groups
Public title
Comparison of the hemodynamic changes following tourniquet use in orthopedic surgeries
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1. All patients over 18 years of age who have an indication for upper or lower limb orthopedic surgery with the possibility of using a tourniquet.
2.Consent of the patient
Exclusion criteria:
Discontent
Age below 18 years
History of hypertension
Havin obvious vascular disease
History of taking anticoagulant drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation will be with the help of a table of
random numbers, and patients will be placed in one of two study groups
based on the order of entry into the study and the results of random
number calculations.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the specialist performing the procedure will be aware of the study and the type of procedure being performed, the study will not be blind. However, the analyst of the thesis results, who will analyze the expected outcome, and also the data collector (the thesis owner's intern) will remain unaware of the type of procedure being performed and will be blind to the study; therefore, this study will be conducted as a double-blind study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golshar / Elgoli Street Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
692
Approval date
2023-08-07, 1402/05/16
Ethics committee reference number
IR.TBZMED.REC.1402.358
Health conditions studied
1
Description of health condition studied
Orthopedic surgeries
ICD-10 code
Z47.9
ICD-10 code description
Orthopaedic follow-up care, unspecified
Primary outcomes
1
Description
Stability of the patient's hemodynamic status during surgery
Timepoint
Hemodynamic variables of the patient in the time period before the operation, before filling the tourniquet, with time intervals of 5 minutes until the tourniquet emptying and up to 15 minutes after the tourniquet emptying.
Method of measurement
Patient monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: SBP+100-130 in the lower limb and SBP+50-70 in the upper limb
Category
Other
2
Description
Control group: the routine pressure used in the operation room
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Medical Research & Training Hospital
Full name of responsible person
Dr. Mohammad Reza Bazavar
Street address
Golshar ,Elgoli Street , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
692
Phone
+98 914 412 8296
Email
mrbazavar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
floor 3, Central building No. 2, Tabriz University of medical Sciences, Golgasht Blvd., Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Bazavar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Golshahr
City
Tabriz
Province
East Azarbaijan
Postal code
692
Phone
+98 41 3327 2822
Email
mrbazavar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Bazavar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Golshahr
City
Tabriz
Province
East Azarbaijan
Postal code
692
Phone
+98 41 3327 2822
Email
mrbazavar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Bazavar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Golshahr
City
Tabriz
Province
East Azarbaijan
Postal code
692
Phone
+98 41 3327 2822
Email
mrbazavar@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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After making people unidentifiable, the results will be published in
the form of dissertations and articles
When the data will become available and for how long
After preparing the results
To whom data/document is available
Researchers
Under which criteria data/document could be used
Examining and expanding the results
From where data/document is obtainable
Neda Feizi Ordaklou
Email: Neda.feizi29@gmail.com
What processes are involved for a request to access data/document
Contact by email up to one month after the request