Low-Current Stimulation for Recurrent Laryngeal Nerve Protection During Thyroid Surgery
2026年7月10日 更新者：Siqi Li、The Second Affiliated Hospital of Kunming Medical University
Clinical Utility of Low-Current Stimulation for Recurrent Laryngeal Nerve Protection During Thyroid Surgery: A Single-Center Prospective Randomized Interventional Study
This single-center prospective randomized interventional study evaluated whether intraoperative low-current stimulation could assist recurrent laryngeal nerve localization and reduce temporary recurrent laryngeal nerve injury during thyroid surgery.
研究概览
地位
完全的
详细说明
A total of 150 patients undergoing thyroid surgery at the Second Affiliated Hospital of Kunming Medical University were randomly allocated in a 1:1:1 ratio to conventional anatomical identification, 3 mA low-current stimulation, or 5 mA low-current stimulation.
All participants underwent preoperative and postoperative electronic laryngoscopy.
The primary outcome was temporary recurrent laryngeal nerve injury.
Secondary outcomes included permanent recurrent laryngeal nerve injury, operative duration, intraoperative blood loss, postoperative hospital stay, and stimulation-related adverse events.
研究类型
介入性
注册 (实际的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Yunnan
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Kunming、Yunnan、中国、650000
- The Second Affiliated Hospital of Kunming Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients scheduled for thyroid surgery.
- No history of prior thyroid or neck surgery.
- Normal bilateral vocal cord mobility on preoperative electronic laryngoscopy.
- Written informed consent provided before enrollment.
Exclusion Criteria:
- Preoperative recurrent laryngeal nerve dysfunction.
- Previous neck surgery.
- Incomplete clinical data.
- Severe comorbidities precluding standardized perioperative assessment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control group
Participants underwent conventional anatomical identification and preservation of the recurrent laryngeal nerve during thyroid surgery.
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实验性的：3 mA group
Participants underwent 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification.
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Low-current stimulation at 3 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification.
Response was judged according to visible or palpable laryngeal twitch.
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实验性的：5 mA group
Participants underwent 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification.
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Low-current stimulation at 5 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification.
Response was judged according to visible or palpable laryngeal twitch.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy
大体时间：6 months after surgery
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Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy.
The number of participants meeting this definition will be reported.
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6 months after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Vocal Cord Paresis or Paralysis Persisting at 6 Months, as Assessed by Electronic Laryngoscopy
大体时间：6 months after surgery
|
Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy.
The number of participants meeting this definition will be reported.
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6 months after surgery
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Total Operative Duration in Minutes
大体时间：Intraoperative period
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Total operative duration will be measured in minutes from the initial skin incision to completion of skin closure.
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Intraoperative period
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Intraoperative blood loss
大体时间：Intraoperative period
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Estimated intraoperative blood loss measured in milliliters.
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Intraoperative period
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Duration of Postoperative Hospital Stay in Days
大体时间：From the date of surgery until hospital discharge, assessed up to 30 days after surgery
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Postoperative hospital stay will be calculated as the number of calendar days from the date of surgery to the date of hospital discharge.
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From the date of surgery until hospital discharge, assessed up to 30 days after surgery
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Number of Participants With Stimulation-Related Adverse Events
大体时间：From initiation of intraoperative nerve stimulation through 30 days after surgery
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The number of participants experiencing at least one stimulation-related adverse event will be reported.
Stimulation-related adverse events include suspected thermal injury, arrhythmia, hemodynamic instability, muscle burn, overstimulation, or suspected false-negative nerve localization, as documented in the intraoperative and postoperative medical records.
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From initiation of intraoperative nerve stimulation through 30 days after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Siqi Li、The Second Affiliated Hospital of Kunming Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年6月1日
初级完成 (实际的)
2025年3月1日
研究完成 (实际的)
2025年3月1日
研究注册日期
首次提交
2026年6月26日
首先提交符合 QC 标准的
2026年7月10日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月10日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.