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The effect of dexamethasone local injection during thyroidectomy on postoperative complications: A clinical trial

Protocol summary

Study aim
Determining the effect of local dexamethasone injection during thyroidectomy surgery on postoperative complications
Design
A controlled, parallel-group, triple-blinded, randomized, phase 3 clinical trial on 150 patients. Computer random number method was used for randomization.
Settings and conduct
The type of study is a triple-blind clinical trial (patient, researcher, data analyst) and its place is the educational-therapeutic centers of Isfahan city. The patient and the person collecting the data are not aware of their group, and the sealed envelope is presented to the surgeon in the operating room.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are candidates for total thyroidectomy surgery, having no history of neck radiation therapy Exclusion criteria: previous neck surgeries
Intervention groups
In the systemic dexamethasone group, 8 mg of dexamethasone is injected intravenously immediately before the operation and after induction of anesthesia. In the local dexamethasone group and the control group, the amount of 8 mg of dexamethasone and 8 mg of normal saline will be injected in the operation field after the end of the operation and before closing the operation field.
Main outcome variables
Calcium level the day after surgery; Postoperative pain score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220916055970N1
Registration date: 2023-02-13, 1401/11/24
Registration timing: registered_while_recruiting

Last update: 2023-02-13, 1401/11/24
Update count: 0
Registration date
2023-02-13, 1401/11/24
Registrant information
Name
Hossein Moeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hosseinmoeini6788@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dexamethasone local injection during thyroidectomy on postoperative complications: A clinical trial
Public title
The effect of dexamethasone local injection during thyroidectomy on postoperative complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for total thyroidectomy surgery No previous surgeries in the neck area No history of radiation therapy in the neck area
Exclusion criteria:
Previous surgeries in the neck area
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be placed in blocks of three based on their hospital admission number (for example, numbers 1 to 3 in the first block, numbers 4 to 6 in the second block, and so on). Then in each block based on the table of random numbers 1-9, if the number of 1-3 is selected, the desired person will be assigned to group A, if the number of 4-6 is selected, the desired person will be assigned to group B, and if the number of 7-9 is selected, the desired person will be assigned to group C. Obviously, in one block, if repeated numbers are selected, the number selection will be repeated so that the person enters a different group. At the end, in the same way, groups A, B, and C will be assigned to three groups: systemic dexamethasone, topical dexamethasone, and the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, the researcher, and the person collecting the data are not informed of their group, and the sealed envelope is presented to the surgeon in the operating room
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
Vice Chancellor for Research and Technology, Building No. 4, Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-06-06, 1401/03/16
Ethics committee reference number
IR.MUI.MED.REC.1401.103

Health conditions studied

1

Description of health condition studied
Thyroidectomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Calcium level after surgery
Timepoint
12 and 24 hours after the operation
Method of measurement
Blood test

2

Description
Postoperative pain score
Timepoint
24 hours after the operation
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the systemic dexamethasone group, 8 mg of dexamethasone (DEXAMETHASONE AMP, ALBORZDAROU, 8MG/2ML) was injected intravenously immediately before the operation and after induction of anesthesia.
Category
Prevention

2

Description
Intervention group: In the local dexamethasone group, after the end of the operation and before closing the operation field, 8 mg of dexamethasone (DEXAMETHASONE AMP, ALBORZDAROU, 8MG/2ML) will be injected into the operation field.
Category
Prevention

3

Description
Control group: In the control group, after the operation and before closing the operation field, 8 mg of normal saline (SODIUM CHLORIDE Serum, ALBORZDARU, 0.45% & 1L) will be injected in the operation field.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hossein Moeini
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Building No. 4, Vice Chancellor for Research and Technology, Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@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
Hossein Moeini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Moein67@dr.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Moeini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Moein67@dr.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Moeini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Moein67@dr.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 is kept confidential.
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
Undecided - It is not yet known if there will be 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
Information about the main outcome can be shared.
When the data will become available and for how long
After publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to complete studies
From where data/document is obtainable
Dr. Hossein Moeini, Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
By examining the researcher's request and providing sufficient documentation of his research and the reason for using the data can be provided.
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