Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy (Corthyroid)

Hospital Italiano de Buenos Aires

Status and phase: Unknown; Phase 4

Conditions: Transient Hypoparathyroidism

Treatments: Drug: saline 0.9% NaCl; Drug: phosphate and betamethasone acetate, 2 mL.

Study type: Interventional

Funder types: Other

Identifiers

NCT02652884

2627

Details and patient eligibility

About

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.

Full description

Triple-blind randomized clinical trial

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation.

Treatment:

Drug: phosphate and betamethasone acetate, 2 mL.

Group 2

Placebo Comparator group

Description:

will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.

Treatment:

Drug: saline 0.9% NaCl