To evaluate the effect of corticosteroid injection during cement implantation in preventing heart and respiratory accidents in patients undergoing arthroplasty.
Design
All patients undergoing knee replacement using convenience sampling, after obtaining written consent, are divided into two groups of intervention and control by block randomization. The sample size of this double-blind study will be 200 people, which will be 100 people in each group.
Settings and conduct
In this study, the surgeon will be aware of the type of intervention performed, but the analyst and patients will not be aware of the type of intervention. All patients with knee replacement referred to Hazrat Rasoul and Moheb Mehr hospitals for 4 months in 2021 are divided into two intervention and control groups. The patients in the intervention group will have a hydrocortisone injection during cement placement, which will not be done in the control group.
The patients' data during and after surgery is recorded by the anesthesia technician and then by the nurse, who does not know the type of intervention. After the patient is discharged, the information from the file is recorded in the checklist by a person who knows the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age over 18 years, need for joint replacement, and willingness to participate in the study.
A history of dementia or psychological disorders that affect decision-making power is the criterion for not including in the study.
Intervention groups
In patients in the intervention group, intravenous injection of 100 mg of hydrocortisone during cement implantation is used, which is not done in the control group.
Main outcome variables
Heart rate; Blood Pressure; Oxygen saturation; (pCO2) partial pressure of carbon dioxide؛ power of hydrogen(pH)؛ Bicarbonate (HCO3)؛ Base Excess (BE); Blood sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180528039883N3
Registration date:2021-08-09, 1400/05/18
Registration timing:registered_while_recruiting
Last update:2021-08-09, 1400/05/18
Update count:0
Registration date
2021-08-09, 1400/05/18
Registrant information
Name
Ali Yeganeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
yeganeh471@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-08-16, 1400/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of corticosteroid injection on respiratory indices and vital signs after cement use in knee replacement
Public title
Evaluation of the effect of corticosteroid injection in knee replacement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Need for Arthroplasty
Willingness to participate in the study
Exclusion criteria:
History of dementia or psychiatric and psychological disorders that affect decision-making power
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the participants in the study using inclusion and non-inclusion criteria, to prevent the occurrence of bias in the selection of participants to intervention and control groups, we will use the randomization method to minimize the opinion of researchers in selecting participant to study groups. The block randomization method was used in this study. The size of the blocks is considered to be four and will be selected randomly so that it is not predictable to the participants based on the blocks. First, we will receive using Random Allocation software and by determining the sample size, the number of groups, the type of randomization and is random the order of the blocks in the software output and will be shown in the software output of groups with letters A and B. Then, after selecting each patient based on the inclusion and non-inclusion criteria, the project manager will be informed and he will tell the type of intervention of that patient based on the order of inclusion of patients and compliance with the number mentioned in the randomization output.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, the surgeon will be aware of the type of intervention performed, but the analyst and patients will not be aware of the type of intervention.
The information of all patients is reviewed and recorded in the file by the anesthesia technician during the surgery and after the surgery in the recovery room, and by the nurse after the transfer to the ward who is different depending on the work shift and does not know the type of intervention.
Then, after the patient's discharge, the information is recorded in the checklist by a person who knows the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-04-06, 1400/01/17
Ethics committee reference number
IR.IUMS.REC.1400.025
Health conditions studied
1
Description of health condition studied
Bone Cement Implantation Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of patients with high heart Rate
Timepoint
Before anesthesia, before implanting cement, immediately after implanting cement, and half an hour after implanting cement
Method of measurement
Heart Monitoring
2
Description
Percentage of patients with blood pressure drop
Timepoint
Before anesthesia, before implanting cement, immediately after implanting cement, and half an hour after implanting cement
Method of measurement
Sphygmomanometer
3
Description
Percentage of patients with oxygen saturation drop
Timepoint
Before anesthesia, before implanting cement, immediately after implanting cement, and half an hour after implanting cement
Method of measurement
Pulse Oxymeter
4
Description
pCO2
Timepoint
half an hour after implanting cement
Method of measurement
Arterial Blood Gas
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One venous infusion of one 100 mg/2 ml ampoule of ABURAIHAN Co. hydrocortisone during the cement implantation
Category
Treatment - Drugs
2
Description
Control group: No venous injection of hydrocortisone during the cement implantation
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1000
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul e-Akram Hospital, Niyayesh St, Sattarkhan St.
City
Tehan
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Fax
Email
yeganeh.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul e-Akram Hospital, Niyayesh St, Sattarkhan St.
City
Tehan
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Fax
Email
yeganeh.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul e-Akram Hospital, Niyayesh St, Sattarkhan St.
City
Tehan
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Fax
Email
yeganeh.a@iums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It is possible to share some of the data related to the main outcomes and medical history of the study participants, but information that in any way identifies the study participants will not be available at all.
When the data will become available and for how long
Starting the access period after printing the results
To whom data/document is available
The data will only be made available to researchers at academic centers
Under which criteria data/document could be used
If people request further studies on the data, they can contact the project manager
From where data/document is obtainable
Applicants are required to contact the research project manager
What processes are involved for a request to access data/document
After reviewing the application and the academic environment, the applicant will be provided with the data.