Intraoperative Methylene Blue Spray for the Identification and Preservation of Vital Structures in Thyroidectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Incidence of recurrent laryngeal nerve injury
研究概览
简要总结
This randomized controlled trial aims to evaluate the efficacy of intraoperative methylene blue (MB) spray in improving the identification and preservation of the recurrent laryngeal nerve (RLN) and parathyroid glands (PGs) during thyroidectomy. The study compares outcomes between patients receiving topical MB spray and those undergoing conventional visual dissection alone. Primary outcomes include the incidence of RLN injury and postoperative serum calcium levels.
详细描述
Thyroidectomy is associated with risks of iatrogenic injury to the RLN and PGs, leading to vocal cord paralysis and hypocalcemia. This study investigates whether topical application of methylene blue spray can enhance intraoperative visualization and preservation of these structures. A total of 136 patients with benign multinodular goiter were randomized into two groups: an experimental group receiving MB spray and a control group receiving conventional dissection. RLN injury was assessed via postoperative laryngoscopy, and serum calcium levels were measured at 72 hours postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •benign multinodular goiter scheduled for thyroidectomy.
排除标准
- •Recurrent/metastatic disease
- •Preoperative vocal cord dysfunction
- •Coagulopathy
- •Methylene blue allergy
- •Hepatic/renal impairment
研究组 & 干预措施
Methylene Blue labelling
干预措施: Intraoperative topical methylene blue spray (Procedure)
Conventional Dissection
干预措施: Conventional Dissection (Procedure)
结局指标
主要结局
Incidence of recurrent laryngeal nerve injury
时间窗: 2 hours (at extubation)
Incidence of recurrent laryngeal nerve injury (assessed by indirect laryngoscopy
Postoperative serum calcium levels
时间窗: At 72 hours
Postoperative serum calcium levels
次要结局
未报告次要终点
研究者
Dr. SamiUllah
Doctor
Services Hospital, Lahore