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

  • STATUS
    Recruiting
  • End date
    Mar 27, 2022
  • participants needed
    100
  • sponsor
    Medical Universtity of Lodz
Updated on 27 January 2021
anesthesia
analgesics
postoperative pain
drainage
nausea
discomfort
calcium
blood tests
glucocorticoids
dexamethasone
vomiting
vitamins
antiemetics
parathyroid hormone
oral dexamethasone
emetic
postoperative nausea
postoperative vomiting

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.

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 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 / , 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.

The aim of my study is to evaluate 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.

Patients admitted to the Department of General and Oncological Surgery, Medical University of Lodz with preoperative diagnosis of nontoxic multinodular goitre undergoing total thyroidectomy will be inculded to the study.

After obtaining written informed consent from all participants during a preoperative visit, they will be randomized to the supplementation group and the placebo group. The study will be a prospective, placebo-controlled and double-blind (for patient and surgeon) research.

Intervention: In the supplementation group a single dose of 8mg of dexamethasone will be given orally one hour before surgery (Dexamethasone Krka tablets (8mg), Warsaw, Poland). In the placebo group patients will receive a single tablet of sweetener one hour before operation (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria).

Preoperatively in the group of all enrolled patients (in the supplementation group and in the placebo group) following tests will be measured in serum: blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium, interleukin 1, interleukin 6, interleukin 10, thyroid stimulating hormone, free thyroxine, free triiodothyronine.

Total thyroidectomies with routine identification of the recurrent laryngeal nerves and parathyroid glands via a transverse cervicotomy under general anaesthesia will be performed by 3 experienced surgeons.

During the total thyroidectomy the number of parathyroid glands found intraoperatively will be registered.

At 6 hour after surgery in the group of all enrolled patients following tests will be measured in serum: blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium. In addiction, at 6 hour after surgery the incidence and intensity of symptomatic hypocalcaemia, postoperative pain (according to VAS scale), postoperative nausea and vomiting, postoperative sore throat and hoarseness will be evaluated.

At 24 hour after surgery in the group of all enrolled patients following tests will be measured in serum: blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium, interleukin 1, interleukin 6, interleukin 10. Additionally, the level of interleukin 1, interleukin 6 and interleukin 10 will be evaluated in drainage fluid. In addiction, at 24 hour after surgery the incidence and intensity of symptomatic hypocalcaemia, postoperative pain (according to Visual Analogue Scale - VAS scale), postoperative nausea and vomiting, postoperative sore throat and hoarseness will be evaluated.

The laboratory parameters will be determined by electrochemiluminescence on the Cobas E411 analyzer and spectrophotometric method on the AU680, Beckman Coulter analyzer. 25-hydroxyvitamin D levels will be measured using the chemiluminescent microparticle immunoassay (CMIA) (Architect 25-OHD). Interleukins levels will be determined by enzyme immunoassay method (EIA) (DGR Medtek) on ElizaMat 2 X analyzer.

Hypocalcemic symptoms will be categorized as mild (a tingling sensation and numbness of the hands or feet and perioral numbness) or severe (a positive Chvostek sign, Trousseau sign, tetany, and carpopedal spasms).

Postoperative hypocalcaemia will be defined as corrected calcium levels <2.0 mmol/l, even if recorded in one measurement only.

In both groups participants who will develop postoperative hypoparathyroidism (parathormone level <1.6 pmol/l at 6 or 24 hour after surgery) or symptomatic hypocalcaemia during hospitalisation will be treated with oral calcium (3 g/d - taken 1 g every 8 hours) and vitamin D derivatives (1 ug/d alfacalcidol taken once).

Intravenous calcium gluconate will be administered if symptoms persist despite oral supplementation.

Patients with symptomatic hypocalcaemia will receive supplementation until the symptoms subside. The treatment will be extended to 6 weeks in patients with hypoparathyroidism on the day of discharge.

The data will be statistically analysed. 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. Vitamin D deficiency is probably common in operated patients and postoperative 25-hydroxyvitamin D levels are lower than those measured preoperatively.

The use of oral dexamethasone might be an effective strategy of prevention of complications after total thyroidectomy.

To the best of our knowledge, this is a pioneering study assessing the usefulness of preventive oral dexamethasone supplementation before total thyroidectomy in homogeneous group of patients with nontoxic multinodular goiter undergoing total thyroidectomy.

Details
Condition Vitamin D Deficiency, Postoperative Complication, Vomiting, Hoarseness, Postoperative Nausea, Hypocalcemia, Pain, Postoperative pain, Vitamin Deficiency, Post-Surgical Pain, Post-Operative Nausea and Vomiting, Hypoparathyroidism Postprocedural, Pain (Pediatric), post-operative pain, post-op pain, postoperative complications, postoperative problems, hypocalcaemia
Treatment Total thyroidectomy, Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland)., Placebo oral sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria)., Preoparative blood laboratory tests, Postoperative laboratory blood tests at 6 hour, Postoperative laboratory blood tests at 24 hour, Postoperative laboratory drainage fluid tests at 24 hour, Symptomatic hypocalcaemia at 6 hour, Symptomatic hypocalcaemia at 24 hour, Postoperative pain at 6 hour, Postoperative pain at 24 hour, Postoperative nausea and vomiting at 6 hour, Postoperative nausea and vomiting at 24 hour, Postoperative sore throat and hoarseness at 6 hour, Postoperative sore throat and hoarseness at 24 hour
Clinical Study IdentifierNCT04412694
SponsorMedical Universtity of Lodz
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Postoperative pain or Vitamin Deficiency or Hoarseness or Postoperative Nausea or Post-Operative Nausea and Vomiting or Vitamin D Deficiency or Pain o...?
Do you have any of these conditions: hypocalcaemia or Postoperative pain or Post-Operative Nausea and Vomiting or post-operative pain or Postoperative Complication or Vomiting or Hoarsene...?
Do you have any of these conditions: post-op pain or Post-Surgical Pain or Vomiting or Pain (Pediatric) or Pain or postoperative complications or Vitamin Deficiency or Postoperative pain ...?
Do you have any of these conditions: Post-Surgical Pain or Hypocalcemia or Vomiting or Pain (Pediatric) or Postoperative pain or postoperative complications or hypocalcaemia or Post-Opera...?
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
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