The Effect of Concomitant Administration of Dexamethasone and Vitamin D before Total Thyroidectomy on Temporary Postoperative Hypocalcemia: A Clinical Trial Study

Investigating the effect of preoperative co-administration of dexamethasone and vitamin D on transient hypocalcemia after total thyroidectomy (Determination and comparison of the mean serum calcium levels before and after total thyroidectomy in the study groups based on age, gender, and the indication for thyroidectomy)

This is a double-blind clinical trial with 4 arms conducted on 120 patients. For sequential random allocation, the sample size is divided by 4, and an equal number of codes labeled A, B, C, and D are placed in a bag. Each eligible patient will draw one code from the bag before surgery, which will determine their assigned treatment group.

This study is being conducted at Shahid Jalil Hospital in Yasuj. It is a double-blind study in which both participants and researchers are blinded. Participants provide are unaware of the content of the medication they receive. Similarly, the researchers do not know which group each participant has been assigned to.

Eligible participants are 18–70 years old, without history of diabetes, hypertension, pregnancy, drug addiction, relevant medication use, certain prior surgeries, and conditions affecting calcium, vitamin D, or parathyroid hormone levels.

The "Dexamethasone and Vitamin D" intervention group receives a single intramuscular dose of vitamin D (200,000 IU) and a single intravenous dose of dexamethasone (8 mg) before the surgical incision. The "Vitamin D" group receives only a vitamin D before the incision, and the "Dexamethasone" group receives only dexamethasone. The control group does not receive any placebo medication. Patients who develop hypocalcemia (serum calcium level < 8 mg/dL) will be treated with oral calcium.

Serum calcium levels before and after surgery; average length of hospital stay

For sequential random allocation of participants to the study groups, the sample size is divided by 4, and an equal number of codes labeled A, B, C, and D are placed in a bag. Each eligible participant will draw one code from the bag before surgery, and their treatment group will be determined based on the selected code.

Both participants and researchers are double-blinded in this study. Participants provide informed consent to take part in the study but are unaware of the content of the medication they receive. Similarly, the researchers do not know which group each participant has been assigned to.

Patient data, including demographic information and laboratory results, may be published without revealing the patients' identities.

The access period will begin after the publication of the results.

The study data will be available only to researchers affiliated with academic and scientific institutions.

The data from this study will only be available for use in meta-analyses and systematic reviews.

To request access to the study data, please contact Dr. Saadat Mehrabi, the principal investigator, via email at dr.s.meh544@gmail.com.

The data will be provided to the researcher as soon as possible after the email is received and the request is submitted.