Preoperative Corticosteroids in Autoimmune Thyroid Disease

Indiana University

Status and phase: Enrolling; Phase 4

Conditions: Graves Disease; Hashimoto Disease

Treatments: Drug: Dexamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05435547

10009 (Other Identifier)

Details and patient eligibility

About

This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

Steroids

Experimental group

Description:

Will be given pre-operative corticosteroid regimen

Treatment:

Drug: Dexamethasone

placebo

Placebo Comparator group

Description:

Will be given Placebo

Treatment:

Drug: Placebo