跳至主要内容
临床试验/NCT03911232
NCT03911232已完成不适用

The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve During Thyroid Surgery

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium

研究概览

简要总结

Objectives: The use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (IONM) in thyroid surgery.

详细描述

An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. In as subsequent clinical application study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy

排除标准

  • Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index <18.5 or >35, chronic drug or alcohol abuse

研究组 & 干预措施

Enhanced recovery

Experimental

rocuronium 2 effective dose at anesthesia induction sugammadex after skin incision and before extubation (total 2 mg/kg iv)

干预措施: sugammadex (Drug)

结局指标

主要结局

sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium

时间窗: 1 month each case

Electromyography signal to assess the quality of neuromonitoring

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

I-Cheng Lu

Doctor

Kaohsiung Medical University Chung-Ho Memorial Hospital

研究点 (1)

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