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

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

Interventions

DRUG

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

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

DRUG

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

Preoperative oral supplementation of sweetener in a single dose.

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.

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.

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.

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.

PROCEDURE

Total thyroidectomy

Patients will undergo total thyroidectomy under general anesthesia.

OTHER

Symptomatic hypocalcaemia at 6 hour

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

OTHER

Symptomatic hypocalcaemia at 24 hour

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

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

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

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

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

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

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.

Sponsors & Collaborators

• Medical University of Lodz

  lead OTHER

Principal Investigators

• Anna Grzegory, MD · Medical University of Lodz, Poland

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2022-09-30

Completion

2022-12-31

Countries

• Poland

Study Locations