Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

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.

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Detailed Description

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Triple-blind randomized clinical trial

Conditions

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Transient Hypoparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

phosphate and betamethasone acetate, 2 mL.

Intervention Type DRUG

single dose of intramuscular depot corticosteroid

Group 2

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

Group Type PLACEBO_COMPARATOR

saline 0.9% NaCl

Intervention Type DRUG

single dose of intramuscular placebo

Interventions

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phosphate and betamethasone acetate, 2 mL.

single dose of intramuscular depot corticosteroid

Intervention Type DRUG

saline 0.9% NaCl

single dose of intramuscular placebo

Intervention Type DRUG

Other Intervention Names

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cronodose placebo

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No