The Impact of Preoperative Oral Dexamethasone Supplementation on the Biochemical Parameters and Results of Surgical Treatment in Patients With Nontoxic Multinodular Goiter Undergoing Total Thyroidectomy.
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative hypocalcaemia
研究概览
简要总结
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.
详细描述
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 nerve palsy, and symptomatic postoperative hypocalcaemia associated with postoperative hypoparathyroidism.
Glucocorticoids are well known for their analgesic, anti-inflammatory, immunomodulatory and anti-emetic effects. However, there is little information in the literature on the prophylactic use of glucocorticosteroids in patients undergoing thyroid surgery. In some previous studies, preoperative intravenous dexamethasone supplementation was associated with a reduced incidence of postoperative laryngeal nerve palsy, postoperative hypoparathyroidism, and with less severe postoperative pain, postoperative sore throat, nausea and vomiting. Patients receiving supplementation also had decreased levels of inflammatory biochemical parameters and proinflammatory cytokines.
Vitamin D deficiency is widespread in Poland. Vitamin D status has an impact on the postoperative complications in surgical patients. In previous study serum 25-hydroxyvitamin D is also suggested as a negative acute phase reactant, which has implications for acute and chronic inflammatory diseases. According to the authors, serum 25-hydroxyvitamin D level is an unreliable biomarker of vitamin D status after acute inflammatory insult.
In the early stages of inflammation, phagocytic cells and endothelium secrete proinflammatory cytokines, which include: interleukins: IL-1 α / β, IL-6, IL-8, TNF. The antagonistic group is anti-inflammatory cytokines, which include interleukins: IL-4, -5, -10, -13, produced by Th2 lymphocytes. These cytokines reduce the amount of interleukins secreted by Th1 lymphocytes.
Changes in the levels of proinflammatory and anti-inflammatory cytokines in the postoperative period were found in studies related to the assessment of surgical trauma. Pro-inflammatory interleukin 1 and interleukin 6 play an important role in many biological processes such as inflammation, sepsis and wound healing. Interleukin 6 expression is proportional to the extent of the surgical trauma. In turn, interleukin 10 is known as a cytokine that inhibits cytokine synthesis. Is one of the strongest immunosuppressive agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient's consent
- •adult patients
- •preoperative diagnosis of nontoxic multinodular goiter
- •total thyroidectomy
排除标准
- •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
- •psychiatric disorders
- •corneal ulcers or corneal injuries
- •severe heart failure
- •pheochromocytoma
- •myasthenia gravis
- •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.
研究组 & 干预措施
supplementation 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.
干预措施: Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland). (Drug)
supplementation 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.
干预措施: Preoparative blood laboratory tests (Diagnostic Test)
supplementation 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.
干预措施: Postoperative laboratory blood tests at 6 hour (Diagnostic Test)
supplementation 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.
干预措施: Postoperative laboratory blood tests at 24 hour (Diagnostic Test)
supplementation 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.
干预措施: Postoperative laboratory drainage fluid tests at 24 hour (Diagnostic Test)
supplementation 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.
干预措施: Total thyroidectomy (Procedure)
supplementation 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.
干预措施: Symptomatic hypocalcaemia at 6 hour (Other)
supplementation 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.
干预措施: Symptomatic hypocalcaemia at 24 hour (Other)
supplementation 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.
干预措施: Postoperative pain at 6 hour (Other)
supplementation 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.
干预措施: Postoperative pain at 24 hour (Other)
supplementation 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.
干预措施: Postoperative nausea and vomiting at 6 hour (Other)
supplementation 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.
干预措施: Postoperative nausea and vomiting at 24 hour (Other)
supplementation 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.
干预措施: Postoperative sore throat and hoarseness at 6 hour (Other)
placebo group
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.
干预措施: Placebo oral sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria). (Drug)
placebo group
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.
干预措施: Preoparative blood laboratory tests (Diagnostic Test)
placebo group
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.
干预措施: Postoperative laboratory blood tests at 6 hour (Diagnostic Test)
placebo group
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.
干预措施: Postoperative laboratory blood tests at 24 hour (Diagnostic Test)
placebo group
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.
干预措施: Postoperative laboratory drainage fluid tests at 24 hour (Diagnostic Test)
placebo group
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.
干预措施: Total thyroidectomy (Procedure)
placebo group
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.
干预措施: Symptomatic hypocalcaemia at 6 hour (Other)
placebo group
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.
干预措施: Symptomatic hypocalcaemia at 24 hour (Other)
placebo group
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.
干预措施: Postoperative pain at 6 hour (Other)
placebo group
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.
干预措施: Postoperative pain at 24 hour (Other)
placebo group
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.
干预措施: Postoperative nausea and vomiting at 6 hour (Other)
placebo group
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.
干预措施: Postoperative nausea and vomiting at 24 hour (Other)
placebo group
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.
干预措施: Postoperative sore throat and hoarseness at 6 hour (Other)
placebo group
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.
干预措施: Postoperative sore throat and hoarseness at 24 hour (Other)
结局指标
主要结局
Postoperative hypocalcaemia
时间窗: preoperatively and at 6 and 24 hour after surgery
To evaluate the incidence of laboratory hypocalcaemia (corrected calcium serum level \<2.0 mmol/l), the change in calcium levels and symptomatic hypocalcaemia in the postoperative period in the supplementation group and in the placebo group.
Postoperative hypoparathyroidism
时间窗: preoperatively and at 6 and 24 hour after surgery
To evaluate the incidence of hypoparathyroidism (parathormone serum level \<1.6 pmol/l) and the change in parathormone levels in the postoperative period in the supplementation group and in the placebo group.
次要结局
- Postoperative vomiting on a verbal rating scale(at 6 and 24 hour after surgery)
- Postoperative pain(at 6 and 24 hour after surgery)
- Postoperative nausea on a verbal rating scale(at 6 and 24 hour after surgery)
- Postoperative sore throat on a verbal rating scale(at 6 and 24 hour after surgery)
- Postoperative hoarseness on a verbal rating scale(at 6 and 24 hour after surgery)
研究者
Anna Grzegory
Principal Investigator
Medical University of Lodz