Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
- Conditions
- Transient Hypoparathyroidism
- Interventions
- Drug: saline 0.9% NaCl
- Registration Number
- NCT02652884
- Lead Sponsor
- Hospital Italiano de Buenos Aires
- Brief Summary
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
Triple-blind randomized clinical trial
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- adult
- thyroidectomy postoperative
- prepaid affiliate patients
- allergy
- CKD
- idiophatic thrombocytopenic purpura
- hyperthyroidism
- chronic use of corticoids
- no follicular cancer, nonpapillary
- refusal to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 phosphate and betamethasone acetate, 2 mL. will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation. Group 2 saline 0.9% NaCl will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.
- Primary Outcome Measures
Name Time Method Postoperative Hypocalcemia 3 days Serial postoperative blood samples will be made to detect hypocalcemia (defined as \<8,5 mg/dL)
1. at 1 hour postoperative from skin closure,
2. at 6 hours after surgery
3. 24 hours
4. 72 hours
- Secondary Outcome Measures
Name Time Method Related Adverse Events 30 days 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)
Trial Locations
- Locations (1)
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina