Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Postoperative Hypocalcemia
研究概览
简要总结
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.
详细描述
Triple-blind randomized clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •thyroidectomy postoperative
- •prepaid affiliate patients
排除标准
- •idiophatic thrombocytopenic purpura
- •hyperthyroidism
- •chronic use of corticoids
- •no follicular cancer, nonpapillary
- •refusal to participate
研究组 & 干预措施
Group 1
will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation.
干预措施: phosphate and betamethasone acetate, 2 mL. (Drug)
Group 2
will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.
干预措施: saline 0.9% NaCl (Drug)
结局指标
主要结局
Postoperative Hypocalcemia
时间窗: 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
次要结局
- Related Adverse Events(30 days)