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The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients. (Dexa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412694
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Grzegory, Medical Universtity of Lodz

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 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.

Condition or disease Intervention/treatment Phase
Hypocalcemia Vitamin D Deficiency Postoperative Complications Postoperative Nausea Postoperative Pain Voice Hoarseness Hypoparathyroidism Postprocedural Drug: Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland). Drug: Placebo oral sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria). Diagnostic Test: Preoparative blood laboratory tests Diagnostic Test: Postoperative laboratory blood tests at 6 hour Diagnostic Test: Postoperative laboratory blood tests at 24 hour Diagnostic Test: Postoperative laboratory drainage fluid tests at 24 hour Procedure: Total thyroidectomy Other: Symptomatic hypocalcaemia at 6 hour Other: Symptomatic hypocalcaemia at 24 hour Other: Postoperative pain at 6 hour Other: Postoperative pain at 24 hour Other: Postoperative nausea and vomiting at 6 hour Other: Postoperative nausea and vomiting at 24 hour Other: Postoperative sore throat and hoarseness at 6 hour Other: Postoperative sore throat and hoarseness at 24 hour Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly assigned (coin toss) to the supplementation group (preoperative oral supplementation of dexamethasone (8mg in one dose) taken one hour before surgery) and to the placebo group (preoperative oral supplementation of sweetener taken one hour before surgery).
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official 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.
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: 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.
Drug: Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland).
Preoperative oral dexamathasone supplementation in a single dose of 8mg.
Other Name: Supplementation

Diagnostic Test: Preoparative blood laboratory tests
Preoperative parameters such as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium, interleukin 1β, interleukin 6, interleukin 10, thyroid stimulating hormone, free thyroxine, free triiodothyronin will be measured in serum.
Other Name: preoperative blood test

Diagnostic Test: Postoperative laboratory blood tests at 6 hour
At 6 hour after surgery such parameters as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium will be measured in serum.
Other Name: blood tests 6 hour

Diagnostic Test: Postoperative laboratory blood tests at 24 hour
At 24 hour after surgery such parameters as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium, interleukin 1β, interleukin 6, interleukin 10 will be measured in serum.
Other Name: blood tests 24 hour

Diagnostic Test: Postoperative laboratory drainage fluid tests at 24 hour
At 24 hour after surgery such parameters as interleukin 1β, interleukin 6, interleukin 10 will be measured in drainage fluid.
Other Name: drainage fluid tests 24 hour

Procedure: Total thyroidectomy
Patients will undergo total thyroidectomy under general anesthesia.
Other Name: thyroidectomy

Other: Symptomatic hypocalcaemia at 6 hour
At 6 hour after surgery patients will be assessed for signs of hypocalcaemia.
Other Name: symptoms 6 hour

Other: Symptomatic hypocalcaemia at 24 hour
At 24 hour after surgery patients will be assessed for signs of hypocalcaemia.
Other Name: symptoms 24 hour

Other: Postoperative pain at 6 hour
At 6 hour after surgery the incidence and intensity of postoperative pain will be evaluated according to Visual Analogue Scale (VAS).
Other Name: pain 6 hour

Other: Postoperative pain at 24 hour
At 24 hour after surgery the incidence and intensity of postoperative pain will be evaluated according to Visual Analogue Scale (VAS).
Other Name: pain 24 hour

Other: Postoperative nausea and vomiting at 6 hour
At 6 hour after surgery the incidence and intensity of postoperative nausea and vomiting will be evaluated.
Other Name: nausea 6 hour

Other: Postoperative nausea and vomiting at 24 hour
At 24 hour after surgery the incidence and intensity of postoperative nausea and vomiting will be evaluated.
Other Name: nausea 24 hour

Other: Postoperative sore throat and hoarseness at 6 hour
At 6 hour after surgery the incidence and intensity of postoperative sore throat and hoarseness will be evaluated.
Other Name: hoarseness 6 hour

Placebo Comparator: 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.
Drug: Placebo oral sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria).
Preoperative oral supplementation of sweetener in a single dose.
Other Name: Placebo

Diagnostic Test: Preoparative blood laboratory tests
Preoperative parameters such as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium, interleukin 1β, interleukin 6, interleukin 10, thyroid stimulating hormone, free thyroxine, free triiodothyronin will be measured in serum.
Other Name: preoperative blood test

Diagnostic Test: Postoperative laboratory blood tests at 6 hour
At 6 hour after surgery such parameters as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium will be measured in serum.
Other Name: blood tests 6 hour

Diagnostic Test: Postoperative laboratory blood tests at 24 hour
At 24 hour after surgery such parameters as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium, interleukin 1β, interleukin 6, interleukin 10 will be measured in serum.
Other Name: blood tests 24 hour

Diagnostic Test: Postoperative laboratory drainage fluid tests at 24 hour
At 24 hour after surgery such parameters as interleukin 1β, interleukin 6, interleukin 10 will be measured in drainage fluid.
Other Name: drainage fluid tests 24 hour

Procedure: Total thyroidectomy
Patients will undergo total thyroidectomy under general anesthesia.
Other Name: thyroidectomy

Other: Symptomatic hypocalcaemia at 6 hour
At 6 hour after surgery patients will be assessed for signs of hypocalcaemia.
Other Name: symptoms 6 hour

Other: Symptomatic hypocalcaemia at 24 hour
At 24 hour after surgery patients will be assessed for signs of hypocalcaemia.
Other Name: symptoms 24 hour

Other: Postoperative pain at 6 hour
At 6 hour after surgery the incidence and intensity of postoperative pain will be evaluated according to Visual Analogue Scale (VAS).
Other Name: pain 6 hour

Other: Postoperative pain at 24 hour
At 24 hour after surgery the incidence and intensity of postoperative pain will be evaluated according to Visual Analogue Scale (VAS).
Other Name: pain 24 hour

Other: Postoperative nausea and vomiting at 6 hour
At 6 hour after surgery the incidence and intensity of postoperative nausea and vomiting will be evaluated.
Other Name: nausea 6 hour

Other: Postoperative nausea and vomiting at 24 hour
At 24 hour after surgery the incidence and intensity of postoperative nausea and vomiting will be evaluated.
Other Name: nausea 24 hour

Other: Postoperative sore throat and hoarseness at 6 hour
At 6 hour after surgery the incidence and intensity of postoperative sore throat and hoarseness will be evaluated.
Other Name: hoarseness 6 hour

Other: Postoperative sore throat and hoarseness at 24 hour
At 24 hour after surgery the incidence and intensity of postoperative sore throat and hoarseness will be evaluated.
Other Name: hoarseness 24 hour




Primary Outcome Measures :
  1. Postoperative hypocalcaemia [ Time Frame: 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.

  2. Postoperative hypoparathyroidism [ Time Frame: 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.


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: at 6 and 24 hour after surgery ]
    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.

  2. Postoperative nausea on a verbal rating scale [ Time Frame: at 6 and 24 hour after surgery ]
    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.

  3. Postoperative vomiting on a verbal rating scale [ Time Frame: at 6 and 24 hour after surgery ]
    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.

  4. Postoperative sore throat on a verbal rating scale [ Time Frame: at 6 and 24 hour after surgery ]
    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.

  5. Postoperative hoarseness on a verbal rating scale [ Time Frame: at 6 and 24 hour after surgery ]
    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.


Other Outcome Measures:
  1. Cytokines in serum [ Time Frame: preoperatively and at 6 and 24 hour after surgery ]
    To evaluate the serum levels of cytokines such as interleukin 1β, interleukin 6, interleukin 10 and the change in cytokines levels in the postoperative period in the supplementation group and in the placebo group.

  2. Cytokines in drain fluid [ Time Frame: at 24 hour after surgery ]
    To evaluate the levels of cytokines such as interleukin 1β, interleukin 6, interleukin 10 in the drain fluid in the postoperative period in the supplementation group and in the placebo group.

  3. Calcium phosphate homeostasis [ Time Frame: preoperatively and at 6 and 24 hour after surgery ]
    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.

  4. Vitamin D [ Time Frame: preoperatively and at 6 and 24 hour after surgery ]
    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.

  5. Acute phase proteins [ Time Frame: preoperatively and at 6 and 24 hour after surgery ]
    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.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412694


Contacts
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Contact: Anna Grzegory, MD 695720008 ext +48 an.grzegory@gmail.com

Locations
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Poland
Department of General and Oncological Surgery, Medical University of Lodz Recruiting
Łódź, Łódzkie, Poland, 92-213
Contact: Anna Grzegory, MD    695720008    an.grzegory@gmail.com   
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
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Principal Investigator: Anna Grzegory, MD Medical University of Lodz, Poland
Publications:

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Responsible Party: Anna Grzegory, Principal Investigator, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT04412694    
Other Study ID Numbers: MULODZ nr RNN/133/20/KE
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD will be included in planned publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: starting 6 months after publication
Access Criteria: planned publication, journal website

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Grzegory, Medical Universtity of Lodz:
dexamethasone
hypocalcaemia
hypocalcemic symptoms
postoperative complications
vitamin D deficiency
cytokines
postoperative pain
postoperative nausea
postoperative vomiting
hoarseness
acute phase proteins
hypoparathyroidism
Additional relevant MeSH terms:
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Hoarseness
Dysphonia
Vitamin D Deficiency
Hypocalcemia
Hypoparathyroidism
Pain, Postoperative
Nausea
Postoperative Complications
Postoperative Nausea and Vomiting
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vomiting
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Otorhinolaryngologic Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory