Determining the relationship between the use of methylene blue and the reduction of hypocalcemia after thyroidectomy.
Design
Clinical trial with control group, without randomization, on 54 patients
Settings and conduct
This study will be conducted on patients who are candidates for thyroidectomy surgery in the operating room of Madani Hospital in Karaj. Patients will be divided into intervention and control groups based on inclusion criteria without randomization and based on the surgeon's opinion.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Thyroidectomy for any reason
2. Age over 18 years
Exclusion criteria:
1. History of calcium disorders
2. Abnormal calcium before surgery
3. Metastatic cancers
4. Previous history of thyroid surgery
Intervention groups
Methylene blue 1% (1 mL [10 mg]) will sprayed over the thyroid lobe and perilober area, which include the parathyroid glands, the inferior thyroid artery, and the recurrent laryngeal nerve. After 5 minutes and the parathyroid glands have stained, meticulous dissection and ligation of the terminal branches of the inferior thyroid artery and vein will done to preserve the vessels supplying the parathyroid glands. Subsequently, the gland will be separated from the trachea, followed by an adequate inspection to ensure that no parathyroid glands were inadvertently removed.
The control group also underwent traditional surgery and the parathyroid glands are preserved whenever possible.
Main outcome variables
calcium level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250331065186N1
Registration date:2025-06-28, 1404/04/07
Registration timing:registered_while_recruiting
Last update:2025-06-28, 1404/04/07
Update count:0
Registration date
2025-06-28, 1404/04/07
Registrant information
Name
Abbas Alizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3350 7042
Email address
abbas.alz7676@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-30, 1404/02/10
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of identifying parathyroid glands using methylene blue on reducing hypocalcemia after thyroidectomy
Public title
Methylene blue as identifier of Parathyroid Glands
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Thyroidectomy surgery for any reason
2. Over 18 years of age
Exclusion criteria:
1. History of calcium disorders
2. Abnormal calcium before surgery
3. Metastatic cancers
4. Previous history of thyroid surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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 Alborz University of Medical Sciences
Intervention Group:In this group, patients will undergo a total thyroidectomy procedure following standard surgical protocols, with the addition of methylene blue as an adjunct to facilitate the identification and preservation of the parathyroid glands.The agent used is methylene blue 1%, with a concentration of 10 mg/mL. A total volume of 1 mL (equivalent to 10 mg) will be sprayed once during the surgery using a sterile syringe equipped with a spray nozzle or atomizer. The spray will be applied evenly over the surface of the thyroid lobe and the surrounding area, which includes the likely locations of the parathyroid glands, the recurrent laryngeal nerve, and branches of the inferior thyroid artery.Methylene blue enhances visual differentiation, as the parathyroid glands absorb less dye compared to surrounding tissues, thus helping the surgeon identify and preserve them more effectively. The application of the dye is done only once during the procedure, after full exposure of the thyroid lobe.All other aspects of the surgery are similar to the control group and include the classic open cervical approach, the use of scalpel, electrocautery, suction, and performance of the procedure under general anesthesia. No educational sessions or training interventions will be provided to the surgeons or operating room staff during the study.
Category
Treatment - Surgery
2
Description
Control group: In this group, patients will undergo a total thyroidectomy procedure performed according to the standard protocols, without the use of any adjunctive agents for the identification of the parathyroid glands. Preservation of the parathyroid glands will rely solely on the direct visualization and the experience and skill of the surgeon in distinguishing parathyroid tissue. The surgery will be performed using the classic open cervical approach under general anesthesia. Standard surgical instruments such as scalpel, electrocautery device (Valleylab Force FX, manufactured by Medtronic), and suction will be used throughout the procedure. The general steps of the operation are as follows: a transverse incision will be made along the midline of the neck (Kocher incision); the pretracheal muscles will be retracted; the recurrent laryngeal nerve will be identified and carefully preserved; the thyroid tissue will be identified and completely removed; and maximum effort will be made to preserve the parathyroid glands through direct observation without the use of any dyes or chemical agents. No substances will be used for staining or marking the parathyroid glands. Furthermore, no educational intervention or additional training will be provided to the surgeons or the operating room staff during the study.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani hospital
Full name of responsible person
Mojtaba Ahmadi Nejad
Street address
Jahanshahr, Madani Hospital
City
Karaj
Province
Alborz
Postal code
3143744693
Phone
+98 26 3330 0000
Email
Mojtaba.ahmadinejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Research and Technology Deputy, Safarian Alley, 45-Meter Golshahr, Karaj, Iran
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Karaj University of Medical Sciences
Full name of responsible person
Abbas Alizade
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Surgery
Street address
Madani hospital, Madani square, Jahanshahr, karaj
City
Karaj
Province
Alborz
Postal code
۳۱۸۵۸۱۹۳۲۸
Phone
+98 26 3350 7042
Fax
Email
Abbas.alz7676@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Abbas Alizade
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Surgery
Street address
Madani Hospital, Madani Square, Jahanshahr Karaj
City
Karaj
Province
Alborz
Postal code
۳۱۸۵۸۱۹۳۲۸
Phone
+98 26 3350 7042
Fax
Email
Abbas.alz7676@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Abbas Alizade
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Surgery
Street address
Madani Hospital, Madani Square, Jahanshahr, Karaj
City
Karaj
Province
Alborz
Postal code
۳۱۸۵۸۱۹۳۲۸
Phone
+98 26 3350 7042
Fax
Email
Abbas.alz7676@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available