The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised … (NCT04412694) | Clinical Trial Compass
UnknownPhase 4
The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients.
Poland100 participantsStarted 2020-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 medic…
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative hypocalcaemia
Timeframe: preoperatively and at 6 and 24 hour after surgery
2
Postoperative hypoparathyroidism
Timeframe: preoperatively and at 6 and 24 hour after surgery