Postoperative Pain Clinical Trial
— DexaOfficial title:
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.
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Poland | Department of General and Oncological Surgery, Medical University of Lodz | Lódz | Lódzkie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Lodz |
Poland,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cytokines in serum | To evaluate the serum levels of cytokines such as interleukin 1ß, interleukin 6, interleukin 10 and the change in cytokines levels in the postoperative period in the supplementation group and in the placebo group. | preoperatively and at 6 and 24 hour after surgery | |
Other | Cytokines in drain fluid | To evaluate the levels of cytokines such as interleukin 1ß, interleukin 6, interleukin 10 in the drain fluid in the postoperative period in the supplementation group and in the placebo group. | at 24 hour after surgery | |
Other | Calcium phosphate homeostasis | To evaluate the serum levels of alkaline phosphatase,inorganic phosphates and magnesium and the change in their levels in the postoperative period in the supplementation group and in the placebo group. | preoperatively and at 6 and 24 hour after surgery | |
Other | Vitamin D | To evaluate the levels of 25-hydroxyvitamin D in the preoperative and postoperative period and the change in its levels in the supplementation group and in the placebo group. To evaluate the incidence of vitamin D deficiency in the group of operated patients. | preoperatively and at 6 and 24 hour after surgery | |
Other | Acute phase proteins | To evaluate the serum levels of albumin, C reactive protein, procalcitonin and fibrinogen and the change in their levels in the postoperative period in the supplementation group and in the placebo group. | preoperatively and at 6 and 24 hour after surgery | |
Primary | Postoperative hypocalcaemia | 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. | preoperatively and at 6 and 24 hour after surgery | |
Primary | Postoperative hypoparathyroidism | 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. | preoperatively and at 6 and 24 hour after surgery | |
Secondary | Postoperative pain | To evaluate the intensity of postoperative pain according to Visual Analogue Scale (VAS scale) in the postoperative period in the supplementation group and in the placebo group. Minimum value is 0 (no pain) and maximum value is 10 (the worst possible pain). Higher scores mean a worse outcome. | at 6 and 24 hour after surgery | |
Secondary | Postoperative nausea on a verbal rating scale | To evaluate the incidence and the intensity of postoperative nausea in the postoperative period in the supplementation group and in the placebo group. The intensity of nausea will be rated on a verbal rating scale based on verbal responses of the patient to questions: 0 - no nausea; 1 - mild nausea (1 episode of nausea); 2 - moderate nausea (2 or 3 episodes of nausea ); and 3 - severe nausea (>3 episodes of nausea ). Higher scores mean a worse outcome. | at 6 and 24 hour after surgery | |
Secondary | Postoperative vomiting on a verbal rating scale | To evaluate the incidence and the intensity of postoperative vomiting in the postoperative period in the supplementation group and in the placebo group.The intensity of vomiting will be rated on a verbal rating scale based on verbal responses of the patient to questions: 0 - no episodes of vomiting; 1 - mild vomiting (1 episode of vomiting); 2 - moderate vomiting (2 or 3 episodes of vomiting); and 3 - severe vomiting (>3 episodes of vomiting).Higher scores mean a worse outcome. | at 6 and 24 hour after surgery | |
Secondary | Postoperative sore throat on a verbal rating scale | To evaluate the incidence and the intensity of postoperative sore throat in the postoperative period in the supplementation group and in the placebo group. Postoperative sore throat will be defined as discomfort at larynx or pharynx at rest and during swallowing after surgery. The intensity of sore throat will be rated on a verbal rating scale based on verbal responses of the patient to questions: 0 - none; 1 - mild sore throat (less severe than with a cold); 2 - moderate sore throat (similar with a cold); and 3 - severe sore throat (more severe than with a cold). Higher scores mean a worse outcome. | at 6 and 24 hour after surgery | |
Secondary | Postoperative hoarseness on a verbal rating scale | To evaluate the incidence and the intensity of postoperative hoarseness in the postoperative period in the supplementation group and in the placebo group. The intensity of hoarseness will be rated on a verbal rating scale based on verbal responses of the patient to questions: 0 - none; 1 - mild hoarseness (noticed by the patient only); 2 - severe hoarseness (obvious to observer); 3 - aphonia (silence of voice). Higher scores mean a worse outcome. | at 6 and 24 hour after surgery |
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