Preoperative Corticosteroids in Autoimmune Thyroid Disease

• Dexamethasone (Drug): Will take Dexamethasone pre-operatively
• Placebo (Drug): Will take Placebo pre-operatively

Primary outcomes

• Thyroid difficulty Scale score [Day of Surgery]: This scale is completed by the surgeon to assess the difficulty of a thyroid operation, and includes 4 parameters (vascularity, friability, mobility/fibrosis, and gland size). The scale ranges from 4 points (best outcome) - 20 points (worst outcome). Higher scores indicate a more difficult operation.

Secondary outcomes

• Change in blood flow / vascularity [Pre-operative visit and Day of Surgery]: The surgeon will use ultrasound to assess the vascularity of the surgical area. Scoring is dependent on thyroid gland size, whether there is substernal extension, and the level of vascularity. The minimum score (2) indicates normal vascularity and normal gland size with no substernal extension. The maximum score (11) indicates extensive vascularity and large gland size with substernal extension.
• Surgical complication of transient hypocalcemia [Two weeks post-operative and six weeks post-operative]: Number of subjects with transient hypocalcemia (calcium <8.5)
• Surgical complication of permanent hypocalcemia [through study completion, or 6 months]: Number of subjects with permanent hypocalcemia (calcium <8.5)
• Surgical complication of transient hypoparathyroidism [Two weeks post-operative and six weeks post-operative]: Number of subjects with Post-op PTH <10
• Surgical complication of permanent hypoparathyroidism [through study completion, or 6 months]: Number of subjects with Post-op PTH <10
• Surgical complication of recurrent laryngeal nerve palsy [Two weeks post-operative and six-weeks post-operative, if clinically indicated]: Vocal cord dysfunction will be evaluated through voice assessment and/or flexible laryngoscopy
• Change in SF-20 at 6 weeks [Six weeks post-operative]: score ranges from 0 to 100, higher scores indicate better functioning or quality of life
• Change in SF-20 at 6 months [through study completion, an average of 6 months]: score ranges from 0 to 100, higher scores indicate better functioning or quality of life
• Tg [through study completion, an average of 6 months]: Tg, 1.3-31.8 ng/mL;
• TgAB [through study completion, an average of 6 months]: TgAB, 0-4.0 IU/mL;
• TPO [through study completion, an average of 6 months]: TPO AB 0-9.0 IU/mL;
• TSI [through study completion, an average of 6 months]: TSI 0-0.54 IU/L;
• TRAb [through study completion, an average of 6 months]: TRAb 0-1.75 IU/L
• ThyPRO [through study completion, an average of 6 months]: 0 points (best outcome) - 340 points (worst outcome)

Sex: All, ages: 18 Years to any

* Inclusion Criteria:

  ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.
* Exclusion Criteria:

  * Pediatric patients < 18
  * Prior treatment with RAI
  * Prior neck surgeries
  * Known diagnosis of thyroid cancer
  * Diabetic patients on medications
  * A history of adverse reactions to corticosteroids.
  * Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.

• Alexandria McDow, MD, Principal investigator, Indiana University