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

NCT04412694 | Unknown Phase 4

• 1 other identifier: MULODZ nr RNN/133/20/KE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypocalcemia; Vitamin D Deficiency; Postoperative Complications; Postoperative Nausea; Postoperative Pain; Voice Hoarseness; Hypoparathyroidism Postprocedural

Keywords

dexamethasone; hypocalcaemia; hypocalcemic symptoms; postoperative complications; vitamin D deficiency; cytokines; postoperative pain; postoperative nausea; postoperative vomiting; hoarseness; acute phase proteins; hypoparathyroidism

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Postoperative pain

  at 6 and 24 hour after surgery

• Postoperative nausea on a verbal rating scale

  at 6 and 24 hour after surgery

• Postoperative vomiting 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

Other Outcomes (5)

• Cytokines in serum

  preoperatively and at 6 and 24 hour after surgery

• Cytokines in drain fluid

  at 24 hour after surgery

• Calcium phosphate homeostasis

  preoperatively and at 6 and 24 hour after surgery

Study Arms (2)

supplementation group

EXPERIMENTAL

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).; 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

placebo group

PLACEBO COMPARATOR

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).; 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

Interventions

Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland). DRUG

Preoperative oral dexamathasone supplementation in a single dose of 8mg.

Also known as: Supplementation

supplementation group

Placebo oral sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria). DRUG

Preoperative oral supplementation of sweetener in a single dose.

Also known as: Placebo

placebo group

Preoparative blood laboratory tests DIAGNOSTIC_TEST

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.

Also known as: preoperative blood test

placebo group; supplementation group

Postoperative laboratory blood tests at 6 hour DIAGNOSTIC_TEST

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.

Also known as: blood tests 6 hour

placebo group; supplementation group

Postoperative laboratory blood tests at 24 hour DIAGNOSTIC_TEST

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.

Also known as: blood tests 24 hour

placebo group; supplementation group

Postoperative laboratory drainage fluid tests at 24 hour DIAGNOSTIC_TEST

At 24 hour after surgery such parameters as interleukin 1β, interleukin 6, interleukin 10 will be measured in drainage fluid.

Also known as: drainage fluid tests 24 hour

placebo group; supplementation group

Total thyroidectomy PROCEDURE

Patients will undergo total thyroidectomy under general anesthesia.

Also known as: thyroidectomy

placebo group; supplementation group

Symptomatic hypocalcaemia at 6 hour OTHER

At 6 hour after surgery patients will be assessed for signs of hypocalcaemia.

Also known as: symptoms 6 hour

placebo group; supplementation group

Symptomatic hypocalcaemia at 24 hour OTHER

At 24 hour after surgery patients will be assessed for signs of hypocalcaemia.

Also known as: symptoms 24 hour

placebo group; supplementation group

Postoperative pain at 6 hour OTHER

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

Also known as: pain 6 hour

placebo group; supplementation group

Postoperative pain at 24 hour OTHER

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

Also known as: pain 24 hour

placebo group; supplementation group

Postoperative nausea and vomiting at 6 hour OTHER

At 6 hour after surgery the incidence and intensity of postoperative nausea and vomiting will be evaluated.

Also known as: nausea 6 hour

placebo group; supplementation group

Postoperative nausea and vomiting at 24 hour OTHER

At 24 hour after surgery the incidence and intensity of postoperative nausea and vomiting will be evaluated.

Also known as: nausea 24 hour

placebo group; supplementation group

Postoperative sore throat and hoarseness at 6 hour OTHER

At 6 hour after surgery the incidence and intensity of postoperative sore throat and hoarseness will be evaluated.

Also known as: hoarseness 6 hour

placebo group; supplementation group

Postoperative sore throat and hoarseness at 24 hour OTHER

At 24 hour after surgery the incidence and intensity of postoperative sore throat and hoarseness will be evaluated.

Also known as: hoarseness 24 hour

placebo group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient's consent
• adult patients
• preoperative diagnosis of nontoxic multinodular goiter
• total thyroidectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of General and Oncological Surgery, Medical University of Lodz

Lodz, Łódź Voivodeship, 92-213, Poland

RECRUITING

Related Publications (11)

• Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Lancione L, Amicucci G. Dexamethasone for the prevention of recurrent laryngeal nerve palsy and other complications after thyroid surgery: a randomized double-blind placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 May;139(5):471-8. doi: 10.1001/jamaoto.2013.2821.

  PMID: 23681030 BACKGROUND

• Yang C, Jung SM, Bae YK, Park SJ. The effect of ketorolac and dexamethasone on the incidence of sore throat in women after thyroidectomy: a prospective double-blinded randomized trial. Korean J Anesthesiol. 2017 Feb;70(1):64-71. doi: 10.4097/kjae.2017.70.1.64. Epub 2016 Nov 25.

  PMID: 28184269 BACKGROUND

• Calkosinski I, Dobrzynski M, Calkosinska M, Seweryn E, Bronowicka-Szydelko A, Dzierzba K, Ceremuga I, Gamian A. [Characterization of an inflammatory response]. Postepy Hig Med Dosw (Online). 2009 Sep 3;63:395-408. Polish.

  PMID: 19745226 BACKGROUND

• Waldron JL, Ashby HL, Cornes MP, Bechervaise J, Razavi C, Thomas OL, Chugh S, Deshpande S, Ford C, Gama R. Vitamin D: a negative acute phase reactant. J Clin Pathol. 2013 Jul;66(7):620-2. doi: 10.1136/jclinpath-2012-201301. Epub 2013 Mar 1.

  PMID: 23454726 BACKGROUND

• Bennett NT, Schultz GS. Growth factors and wound healing: biochemical properties of growth factors and their receptors. Am J Surg. 1993 Jun;165(6):728-37. doi: 10.1016/s0002-9610(05)80797-4.

  PMID: 8506974 BACKGROUND

• Gailit J, Clark RA. Wound repair in the context of extracellular matrix. Curr Opin Cell Biol. 1994 Oct;6(5):717-25. doi: 10.1016/0955-0674(94)90099-x.

  PMID: 7530463 BACKGROUND

• Sakamoto K, Arakawa H, Mita S, Ishiko T, Ikei S, Egami H, Hisano S, Ogawa M. Elevation of circulating interleukin 6 after surgery: factors influencing the serum level. Cytokine. 1994 Mar;6(2):181-6. doi: 10.1016/1043-4666(94)90040-x.

  PMID: 8032001 BACKGROUND

• Kalayci D, Dikmen B, Kacmaz M, Taspinar V, Ornek D, Turan O. [Plasma levels of interleukin-10 and nitric oxide in response to two different desflurane anesthesia flow rates]. Braz J Anesthesiol. 2014 Jul-Aug;64(4):292-8. doi: 10.1016/j.bjan.2013.06.009. Epub 2014 Jun 3. Portuguese.

  PMID: 25096778 BACKGROUND

• Delogu G, Antonucci A, Signore M, Marandola M, Tellan G, Ippoliti F. Plasma levels of IL-10 and nitric oxide under two different anaesthesia regimens. Eur J Anaesthesiol. 2005 Jun;22(6):462-6. doi: 10.1017/s0265021505000797.

  PMID: 15991511 BACKGROUND

• Turan A, Hesler BD, You J, Saager L, Grady M, Komatsu R, Kurz A, Sessler DI. The association of serum vitamin D concentration with serious complications after noncardiac surgery. Anesth Analg. 2014 Sep;119(3):603-612. doi: 10.1213/ANE.0000000000000096.

  PMID: 25121616 BACKGROUND

• Pludowski P, Ducki C, Konstantynowicz J, Jaworski M. Vitamin D status in Poland. Pol Arch Med Wewn. 2016 Aug 9;126(7-8):530-9. doi: 10.20452/pamw.3479. Epub 2016 Aug 9.

  PMID: 27509842 BACKGROUND

MeSH Terms

Conditions

Hypocalcemia; Vitamin D Deficiency; Postoperative Complications; Postoperative Nausea and Vomiting; Pain, Postoperative; Hoarseness; Hypoparathyroidism

Interventions

Dexamethasone; Dietary Supplements; Sweetening Agents; Hematologic Tests; Thyroidectomy

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Anna Grzegory, MD

  Medical University of Lodz, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Grzegory, MD

CONTACT

695720008; an.grzegory@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: June 2, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• Access Criteria: planned publication, journal website

Locations

PL (1)