Thyroid Dysfunction in Head and Neck Surgery Patients Treated With Intraoperative Oral Administration With Povidone-iodine 10% Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Thyroid dysfunction in head and neck surgery patients
研究概览
简要总结
Specific Aim I: Determine absorption of iodine after oropharyngeal application of povidone-iodine 10% solution when used in head and neck surgery involving the upper aero-digestive tract.
Specific Aim II: Measurement of iodine induced changes in thyroid function.
详细描述
Serial blood draws will be obtained from approximately 10 men and women age 18 and over who have been exposed to intraoperative oropharyngeal application with povidone-iodine 10%. Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. A postoperative 24-hour urine iodine level will also be obtained. With the above measurements, the amount of iodine absorption as well as the time period of peak absorption and duration of elevated iodine levels will be elucidated.
Thyroid hormone metabolism is highly dependent on serum levels of iodine. Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. Measuring thyroid function is important since hypothyroidism has been known to have a major impact on postoperative wound healing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients undergoing any head and neck surgery requiring entry into the upper aerodigestive tract and thus necessitating the oral administration of the antimicrobial agent povidone-iodine 10%.
排除标准
- •Patients with history of hypothyroidism currently taking thyroid hormone medications (i.e. Synthroid, Levothyroxine, Thyroxine) and women who are pregnant.
结局指标
主要结局
Thyroid dysfunction in head and neck surgery patients
时间窗: Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours and 1 week after exposure.
Specific Aim I: Determine absorption of iodine after oropharyngeal application of povidone-iodine 10% solution when used in head and neck surgery involving the upper aero-digestive tract.
次要结局
- Thyroid dysfunction in head and neck surgery patients(Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours and 1 week after exposure.)