Status:
UNKNOWN
The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients.
Lead Sponsor:
Medical University of Lodz
Conditions:
Hypocalcemia
Vitamin D Deficiency
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief 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 postoperativ...
Detailed Description
Recovery time after thyroid surgery may depend on several factors, such as postoperative pain, nausea and vomiting, postoperative sore throat, phonation disorders associated with recurrent laryngeal n...
Eligibility Criteria
Inclusion
- patient's consent
- adult patients
- preoperative diagnosis of nontoxic multinodular goiter
- total thyroidectomy
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04412694
Start Date
July 1 2020
End Date
December 1 2022
Last Update
February 8 2022
Active Locations (1)
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1
Department of General and Oncological Surgery, Medical University of Lodz
Lodz, Łódź Voivodeship, Poland, 92-213