Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter

Last updated: February 6, 2026
Sponsor: Jan Calissendorff
Overall Status: Active - Recruiting

Phase

3

Condition

Thyroid Disease

Thyroid Disorders

Female Hormonal Deficiencies/abnormalities

Treatment

Iodine-Potassium Iodide 5%-10% Oral and Topical Solution

Clinical Study ID

NCT04856488
LugolProtocol001
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy can reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 <30 pmol/L or Graves' disease

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Unstable coronary artery disease

  • Previous thyroid surgery

  • Congestive heart failure

  • Renal insufficiency

  • Hepatic failure

  • Current infection

  • Treatment with steroids or anticoagulants

  • Thyroid associated orbitopathy CAS > 2

  • Diabetes mellitus type 1

  • Active cancer

  • Severe psychiatric illness

  • Amiodarone treatment

  • Pregnancy

  • Breast feeding

  • Women of child bearing potential not using contraceptive

  • Inability to comprehend the meaning of the study

  • Iodine hypersensitivity

Study Design

Total Participants: 182
Treatment Group(s): 1
Primary Treatment: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution
Phase: 3
Study Start date:
November 18, 2021
Estimated Completion Date:
December 31, 2028

Study Description

Current practice in Sweden before thyroidectomy due to hyperthyroidism is preoperative treatment with antithyroid drugs (ATD) to all patients with Graves' disease and in cases of toxic nodular goiter with pronounced hyperthyroidism. Iodine solution is administered preoperatively in selected cases of Graves' disease where ATD is intolerable. In the cases where iodine is used it is in the form of extemporaneous prepared iodine potassium iodide solution (Lugol 5%). The dose varies in clinical studies. In American and Swedish guidelines the dose is 5-10 drops 3 times per day for 10 days prior to surgery. American guidelines recommend iodine as preoperative treatment i Graves' disease but this is based on sparse evidence. Iodine as preoperative treatment in toxic nodular goiter has yet not been studied.

The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy due to hyperthyroidism reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy.

Before including toxic nodular goiters accepted for surgery, a pilot study will be performed on 20 patients with toxic nodular goiter. They will receive Lugol solution 3 times per day for ten days and thyroid hormone levels will be measured day 0, day 3-4, day 6-7 and after 10 days of Lugol treatment. Heart rate assessed and ThyPRO39 filled out before and after treatment.

Connect with a study center

  • Department of Endocrinology, Karolinska University Hospital

    Solna, Stockholm 17176
    Sweden

    Site Not Available

  • Department of Endocrinology, Karolinska University Hospital

    Solna 2675397, Stockholm County 2673722 17176
    Sweden

    Active - Recruiting

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