The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients. (Dexa)
Hypocalcemia, Vitamin D Deficiency, Postoperative Complications
About this trial
This is an interventional prevention trial for Hypocalcemia focused on measuring dexamethasone, hypocalcaemia, hypocalcemic symptoms, postoperative complications, vitamin D deficiency, cytokines, postoperative pain, postoperative nausea, postoperative vomiting, hoarseness, acute phase proteins, hypoparathyroidism
Eligibility 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.
Sites / Locations
- Department of General and Oncological Surgery, Medical University of LodzRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
supplementation group
placebo group
Patients will receive preoperative oral supplementation of 8mg of dexamethasone (Dexamethasone Krka tablets (8mg), Warsaw, Poland) in a single dose taken once one hour before surgery. At 6 and 24 hour after surgery, clinical and laboratory parameters will be measured and evaluated.
Patients will receive preoperative oral supplementation of sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria) taken once in a single dose one hour before surgery. At 6 and 24 hour after surgery, clinical and laboratory parameters will be measured and evaluated.