Randomized Controlled Trial on Efficacy of Preemptive 8 mg of Dexamethasone for Reducing Pain and Postoperative Nausea and Vomit After Thyroidectomy for Benign Disease.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative nausea and vomit (PONV) measured in 4 grades
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal function after thyroidectomy for benign disease.
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
- Triple (Participant, 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
- •Age > 18 years
- •Patients undergoing thyroidectomy
排除标准
- •Patients who had received antiemetic therapy within 48 hours before surgery
- •Patients with depression
- •Chronic pain disorder
- •Insulin-dependent diabetes mellitus
- •History of severe and/or repeated PONV after previous minor surgery, that led to change from standard anesthetic protocol
- •Pregnancy
- •Age < 18 years
- •Patients who had known malignant disease or had undergone previous thyroid or neck surgery
研究组 & 干预措施
A (dexamethasone)
20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
干预措施: Dexamethasone (Drug)
A (dexamethasone)
20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
干预措施: Thyroidectomy, total or partial (Procedure)
B (Control)
20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
干预措施: saline solution (Drug)
B (Control)
20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
干预措施: Thyroidectomy, total or partial (Procedure)
结局指标
主要结局
Postoperative nausea and vomit (PONV) measured in 4 grades
时间窗: 8, 24, 32 and 48 hours after surgery
次要结局
- Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale(8, 24, 32 and 48 hours after surgery)
- Vocal function measured in a 0-100 Visual analog scale(8, 24, 32 and 48 hours after surgery)
研究者
Marco Scatizzi
Md
Ospedale Misericordia e Dolce