The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients.

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Glucocorticoids are well known for their analgesic, anti-inflammatory, immunomodulatory and anti-emetic effects. Recovery time after thyroid surgery may depend on several factors, such as postoperative pain, nausea and vomiting, postoperative sore throat, voice disorders and symptomatic hypocalcaemia (low serum calcium level). However, there is little information in the literature about the preventive use of glucocorticosteroids in patients undergoing thyroid surgery. The aim of the study is to evaluate the clinical impact of preoperative oral dexamethasone supplementation on the surgical outcome in patients with multinodular goiter undergoing total thyroidectomy. Patients will be assigned to the supplementation group and the placebo group. In the supplementation group 8mg of dexamethasone will be administered orally one hour before surgery. In the postoperative period, the frequency and intensity of pain, nausea, vomiting, sore throat and hoarseness will be assessed. The incidence of symptoms of hypocalcaemia will also be evaluted. Preoperative and postoperative levels of vitamin D, cytokines, acute phase proteins and substances related to calcium metabolism will be measured in the blood. Cytokines levels in drainage fluid will also be assessed. The main hypothesis of the study is that in patients with supplementation postoperative discomfort and decrease in serum calcium and parathormone level and hypocalcemic symptoms will be less severe and the levels of proinflammatory substances will be decreased.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lodz; Medical Universtity of Lodz
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• patient's consent

• adult patients

• preoperative diagnosis of nontoxic multinodular goiter

• total thyroidectomy

Exclusion Criteria:

• lack of patient's consent

• hyperthyroidism currently or in the past

• retrosternal goiter

• thyroid malignanacy or suspected malignant thyroid tumor

• parathyroids disease

• malingant tumor in any location currently or in the past

• state after neck surgery

• state after radiotherapy

• bone diseases, osteoporosis

• sarcoidosis

• liver failure, hepatitis

• kidney stones, kidney failure (eGFR<60ml/min/1.73m2)

• taking nonsteroidal anti-inflammatory drugs

• steroid treatment

• stomach and duodenal ulcer disease currently or in the past

• active infection at the time of the study

• history of tuberculosis

• a period of 8 weeks before and 2 weeks after administration of the live vaccine

• unregulated hypertension

• diabetes

• psychiatric disorders

• glaucoma

• corneal ulcers or corneal injuries

• severe heart failure

• pheochromocytoma

• myasthenia gravis

• epilepsy

• head injury

• ulcerative colitis

• diverticulitis

• pregnancy

• breast-feeding

• hypokalaemia

• galactose intolerance

• lactase deficiency

• dexamethasone allergy, allergic to lactose, allergic to gelatinized starch, allergic to corn starch, allergic to colloidal anhydrous silica, allergic to magnesium stearate

• allergic reaction to substances contained in the sweetener: sodium cyclamate, sodium saccharin, sodium bicarbonate, sodium citrate.

• taking medications that affect calcium metabolism: anti-resorptive drugs, anabolic drugs, bisphosphonates, systemic glucocorticosteroids, thiazide diuretics, furosemide, proton pump inhibitors, antacids containing magnesium or aluminum salts, cholestyramine, colestipol, paraffin oil, salicylates, estrogen-containing oral contraceptives (hormonal contraceptives) , preparations containing calcium salts (regular intake), preparations of vitamin D or its analogues (regular intake)

• taking medications that increase the side effect of dexamethasone or enter into drug interactions with dexamethasone: acetazolamide, loop diuretics, thiazide diuretics, diuretics, amphotericin B, glucocorticosteroids, mineralocorticosteroids, tetracosactide and laxatives, carbenoxolone, chlorokine, hydroxychlorokine and meflocin, angiotensin converting enzyme inhibitors, thalidomide, cholinesterase inhibitors in patients with myasthenia gravis, fluorochonolones, ephedrine, barbiturates, rifabutin, rifampicin, phenytoin and carbamazepine, aminoglutethimide, bile acid binding resins, such as cholestyramine, antacids,activated carbon, antifungal azoles, ketoconazole, HIV protease inhibitors, macrolide antibiotics, estrogens, anti-tuberculosis drugs (isoniazid), cyclosporin, praziquantel, oral anticoagulants (coumarin), atropine and other anticholinergic drugs, somatotropin, protirel.