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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.
Triple-blind randomized clinical trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation. |
|
| Group 2 | Placebo Comparator | will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phosphate and betamethasone acetate, 2 mL. | Drug | single dose of intramuscular depot corticosteroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hypocalcemia | Serial postoperative blood samples will be made to detect hypocalcemia (defined as <8,5 mg/dL)
| 3 days |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego H Giunta, MD | Contact | diego.giunta@hospitalitaliano.org.ar | ||
| Juan Achaval Rodriguez, MD | Contact | juan.achaval@hospitalitaliano.org.ar |
| Name | Affiliation | Role |
|---|---|---|
| Juan Achaval, MD | Hospital Italiano de Buenos Aires | Principal Investigator |
| Figari Marcelo, MD | Hospital Italiano de Buenos Aires | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Recruiting | Buenos Aires | Buenos Aires F.D. | C1181ACH | Argentina |
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| ID | Term |
|---|---|
| D010710 | Phosphates |
| C580789 | betamethasone acetate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010756 | Phosphoric Acids |
| D017976 | Phosphorus Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
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| saline 0.9% NaCl | Drug | single dose of intramuscular placebo |
|
|
| 30 days |
| D007287 |
| Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D017553 | Phosphorus Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |