Study the Effects of Dexamethasone on Prevention of Transient Hypocalcemia after Total Thyroidectomy
Design
This phase 3 interventional clinical trial will be conducted on 68 patients who are candidates for total thyroidectomy surgery. Patients will be divided into intervention (34 cases) and control (34 cases) groups. In the intervention group, dexamethasone (8 mg) will be injected before total thyroidectomy surgery and 8 and 16 hours after surgery, but subjects in the control group will not receive dexamethasone.
Settings and conduct
68 patients referred to Yasouj hospitals (Imam Sajjad, Shahid Beheshti and Jalil) who are awaiting total thyroidectomy surgery due to thyroid tumor, goiter, treatment-resistant hyperthyroidism, and unilateral thyroid lobectomy will be included in the study and divided into intervention (34 cases) and control (34 cases) groups. In the intervention group, dexamethasone (8 mg) will be injected before total thyroidectomy surgery and 8 and 16 hours after surgery. Subjects in the control group will not receive dexamethasone. The serum calcium level of all patients will be measured every twelve hours for two days. The calcium level less than 8 is considered as hypocalcemia and the patient is treated with oral calcium.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients aged 18 to 70 years, who are candidates for total thyroidectomy surgery due to thyroid tumor, goiter, treatment-resistant hyperthyroidism, and unilateral thyroid lobectomy
Exclusion Criteria:
Patients with Diabetes or Hypertension
Patients who have take Cortone for more than 7 days in the last three months
Pregnant subjects
Intervention groups
Intervention group: intravenous injection of dexamethasone (8 mg) before total thyroidectomy surgery and 8 and 16 hours after surgery
Control group: no dexamethasone injection
Main outcome variables
Measurement of Serum Calcium Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230529058331N1
Registration date:2023-07-03, 1402/04/12
Registration timing:prospective
Last update:2023-07-03, 1402/04/12
Update count:0
Registration date
2023-07-03, 1402/04/12
Registrant information
Name
Mohammad Ostovari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7230
Email address
mo.ostovari82@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the Effects of Dexamethasone on Prevention of Transient Hypocalcemia after Total Thyroidectomy
Public title
Effects of Dexamethasone on Hypocalcemia after Thyroidectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for total thyroidectomy surgery due to thyroid tumor, goiter, treatment-resistant hyperthyroidism, and unilateral thyroid lobectomy
Patients aged between 18 to 70 years old
Patients who have given written consent to participate in the study
Exclusion criteria:
Patients with Diabetes
Patients with Hypertension
Patients who have take Cortone for more than 7 days in the last three months
Pregnant subjects
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.YUMS.REC.1401.169
Health conditions studied
1
Description of health condition studied
Total Thyroidectomy Surgery
ICD-10 code
E07.9
ICD-10 code description
Disorder of thyroid, unspecified
Primary outcomes
1
Description
Measurement of Hypocalcemia
Timepoint
The serum calcium level will be measured every twelve hours for two days in both of the intervention and control groups.
Method of measurement
Venous blood samples will be taken from patients at designated times. After serum separation, the serum calcium level will be measured in all patients. The calcium level less than 8 is considered as hypocalcemia and the patient is treated with oral calcium. Collected data will be analyzed using SPSS software version 21. Descriptive statistics, frequency distribution tables and graphs will be used to describe the data.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, dexamethasone (8 mg) will be injected before total thyroidectomy surgery and 8 and 16 hours after surgery. The serum calcium level of all patients will be measured every twelve hours for two days. A calcium level less than 8 will be considered as hypocalcemia and the patient will be treated with oral calcium.
Category
Prevention
2
Description
Control group: Subjects in the control group will not receive dexamethasone, but the serum calcium level of all patients will be measured every twelve hours for two days. A calcium level less than 8 will be considered as hypocalcemia and the patient will be treated with oral calcium.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Government Hospitals of Yasouj City (Imam Sajjad, Shahid Beheshti, and Jalil).
Full name of responsible person
Mohammad Ostovari
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3333 7001
Email
mo.ostovari82@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari Blvd, Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3334 6078
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Ostovari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari Blvd, Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3333 7001
Email
mo.ostovari82@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Ostovari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari Blvd, Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3333 7001
Email
mo.ostovari82@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Ostovari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Shahid Motahari Blvd, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3333 7001
Email
mo.ostovari82@yahoo.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
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
Yes - There is a plan to make this available
Title and more details about the data/document
Patients are requested to read and sign the written consent form. Then, the demographic data including age, gender, histological diagnosis, pathology results and other relevant data will be collected and recorded. Subjects will be divided into two control and intervention groups and the designed experiments will be performed. At the end of the study, the obtained data will be analyzed and published in an article.
When the data will become available and for how long
The access period starts from 2024
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researches
From where data/document is obtainable
Dr. Mohammad Ostovari
mo.ostovari82@yahoo.com
What processes are involved for a request to access data/document
After the article is published, it is possible to access the data.