Comparison of Sugammadex Dosages to Reverse the Effect of Rocuronium for Continuous Intraoperative Neuromonitoring in Thyroid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Quality of signal of neuromonitoring
研究概览
简要总结
This study was designed to compare two dosage of sugammadex after tracheal intubation for optimal condition of continuous intraoperative neuromonitoring in thyroid surgery to protect recurrent laryngeal nerve.
详细描述
Vocal cord paralysis is not a rare complication in thyroid surgery. Nerve monitoring technique has been developed, and many clinicians use the technique for saving the concerned nerves. Many studies showed that the effect of sugammadex on reverse of neuromuscular blocking after tracheal intubation. However, optimal dosage was not founded for sugammadex.
This randomized controlled trial is to compare 1 mg/kg and 2 mg/kg as dosage of sugammadex for optimal continuous intraoperative neuromonitoring in thyroid surgery to prevent vocal cord paralysis.
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
- Double (Participant, Care Provider)
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
- •The patients who need to open thyroid surgery
排除标准
- •Who doesn't agree to enroll
- •Who has to receive other drug rather than rocuronium for muscle relaxant
研究组 & 干预措施
1 mg/kg
For '1 mg/kg' group, sugammadex of 1 mg/kg (ex. 60 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation.
We will use Sugammadex 200 MG in 2 ML Injection for this.
干预措施: Sugammadex 200 MG in 2 ML Injection (Drug)
2 mg/kg
For '2 mg/kg' group, sugammadex of 2 mg/kg (ex. 120 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation.
We will use Sugammadex 200 MG in 2 ML Injection for this.
干预措施: Sugammadex 200 MG in 2 ML Injection (Drug)
结局指标
主要结局
Quality of signal of neuromonitoring
时间窗: intraoperative
During operation, surgeon evaluate the quality of signal of neuromonitoring on the basis of NIM III device.
次要结局
未报告次要终点
研究者
Jung-Man Lee
Associate professor
Seoul National University Hospital