Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy

Study Overview
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Brief Summary
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The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (TT), given that at present is still the gold standard of treatment. Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications, with an incidence of between 10 and 46% according to different sources. HPT involves longer hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the health system. While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti emetic of corticosteroids in thyroid surgery, the literature available to date is discordant in the use of steroid and its interaction with the HPT making clear the need for randomized clinical trials specific to analyze these variables more accurately. As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of HPT component, investigators decided t conduct a prospective randomized, triple-blind, in order to assess the potential benefits of the most common postoperative complication reported in TT. Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids deposit immediately postintubation in preventing the development of transient hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.

Detailed Description
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Triple-blind randomized clinical trial

Official Title
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Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy

Conditions
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Transient Hypoparathyroidism

Intervention / Treatment
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* Drug: phosphate and betamethasone acetate, 2 mL.
* Drug: saline 0.9% NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult thyroidectomy postoperative prepaid affiliate patients Exclusion Criteria: allergy CKD idiophatic thrombocytopenic purpura hyperthyroidism chronic use of corticoids no follicular cancer, nonpapillary refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation. | Drug: phosphate and betamethasone acetate, 2 mL.<br>* single dose of intramuscular depot corticosteroid<br>* Other names: cronodose;|
| Placebo Comparator: Group 2<br>will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation. | Drug: saline 0.9% NaCl<br>* single dose of intramuscular placebo<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Hypocalcemia | Serial postoperative blood samples will be made to detect hypocalcemia (defined as <8,5 mg/dL) at 1 hour postoperative from skin closure, at 6 hours after surgery 24 hours 72 hours | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Related Adverse Events | Any negative effects of corticosteroids will be also recorded in the postoperative and during 30 days follow up after surgery. Major side effects associated with glucocorticoid therapy are: Gastrointestinal (Gastritis, Peptic ulcer disease, Pancreatitis, Steatohepatitis, Visceral perforation) Dermatologic and soft tissue (Skin thinning and purpura) Cardiovascular (Arrhythmias, Hypertension, Hypotension) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transient hypoparathyroidism, steroids, total thyroidectomy