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A Prospective Randomized Controlled Trial of the Effect of Preoperative Prednisolone Administration on Thyroid Function in Patients with Graves' Disease

A Study of the Effect of Prednisolone Before Surgery on Thyroid Function in Patients with Graves' Disease

Tomiie Yumi

Fujita Health University

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan

yumi.tomiie@fujita-hu.ac.jp

Tomiie Yumi

Fujita Health University

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan

+81-562-93-9033

yumi.tomiie@fujita-hu.ac.jp

Recruiting

Aug. 13, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1. Patients who have received sufficient information about the study, fully understand the study, and provide written informed consent of their own free will.
2. Patients aged 18 years or older at the time of informed consent.
3. Patients diagnosed with Graves' disease and scheduled to undergo total thyroidectomy.
4. Patients who have difficulty taking antithyroid drugs.
5. Patients receiving potassium iodide treatment continuously for at least 7 days.
6. Patients with persistent hyperthyroidism approximately 2 weeks before the scheduled surgery and an FT3 level of 6 pg/mL or higher.
7. Patients for whom at least 7 days of preoperative management can be secured before the scheduled surgery.

1. Patients receiving continuous systemic corticosteroid therapy.
2. Patients with a history of hypersensitivity to prednisolone.
3. Patients with poorly controlled diabetes mellitus, active infection, severe psychiatric disease, or other conditions that may be exacerbated by corticosteroid administration.
4. Patients with severe hepatic or renal dysfunction.
5. Patients who develop thyroid storm before surgery and undergo surgery during its management.
6. Patients for whom an adequate period of standard preoperative management cannot be secured, such as those requiring emergency surgery.
7. Patients considered inappropriate for participation in this study by the principal investigator or a sub-investigator.

Both

Graves' disease

Participants will be randomized in a 1:1 ratio to either the prednisolone group or the non-prednisolone group. Both groups will be hospitalized approximately 2 weeks before surgery and will receive standard preoperative management consisting of continued potassium iodide treatment and rest. In the prednisolone group, prednisolone 10 mg will be administered orally three times daily after each meal and continued until the day before surgery. In the non-prednisolone group, prednisolone will not be administered, and standard preoperative management alone will be continued.

Graves' disease, hyperthyroidism, total thyroidectomy

Prednisolone

D006111

D011239

Percentage change in FT3 from enrollment (approximately 2 weeks before the scheduled surgery) to the day before surgery.
Percentage change in FT3 = (FT3 at enrollment - FT3 on the day before surgery) / FT3 at enrollment x 100.

FT3 normalization rate (proportion of patients whose FT3 level is within the reference range on the day before surgery)
Change in FT4
Change in heart rate
Rate of worsening clinical symptoms (defined as worsening of clinical symptoms such as tachycardia, sweating, and tremor)
Rate of surgery postponement
Rate of initiation of rescue treatment
Intraoperative blood loss
Operation time
Weight of the resected thyroid gland
Length of hospital stay
Adverse events (including hyperglycemia, infection, insomnia, and psychiatric symptoms)

+81-562-93-2865

July. 31, 2026

No

There is no plan to share anonymized individual participant data obtained in this study with other researchers or institutions.

none