Effect of Neuromuscular Blockade on Video Laryngeal Mask Airway Ventilation
2026年9月15日 更新者：Seok Kyeong Oh、Korea University Guro Hospital
The Relationship Between the Degree of Neuromuscular Blockade and the Conditions of Laryngeal Mask Ventilation: A Prospective Randomized Double-Blind Study
This prospective, randomized, double-blind study aims to evaluate the effect of different degrees of neuromuscular blockade on the performance of a video laryngeal mask airway (LMA) during general anesthesia.
Participants will be randomly assigned to receive rocuronium at 0, 0.3, or 0.6 mg/kg, corresponding to 0, 1, or 2 times the ED95, respectively.
The primary outcome is oropharyngeal leak pressure measured after LMA insertion.
Secondary outcomes include LMA insertion conditions, insertion time and number of attempts, laryngeal view, respiratory parameters, and postoperative airway-related complications.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
96
阶段
- 第四阶段
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。
学习联系方式
- 姓名：Seok Kyeong Oh, MD, PhD
- 电话号码：82-2-2626-3234
- 邮箱：nanprayboy@korea.ac.kr
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:
- Scheduled for elective surgery under general anesthesia with a video
- laryngeal mask airway
- Expected duration of surgery less than 3 hours
- Surgery performed in the supine position
- Provision of written informed consent
Exclusion Criteria:
- Symptoms or signs of upper respiratory tract infection
- Increased risk of pulmonary aspiration
- Anticipated difficult airway
- Limited mouth opening (<3 cm)
- Limited head or neck movement
- Mallampati class IV
- Body mass index ≥35 kg/m²
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：其他
- 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 |
|---|---|
|
有源比较器：0 × ED95 Group
Participants receive rocuronium 0 mg/kg (0 × ED95) before video LMA insertion.
|
Normal saline is administered intravenously as the control study drug before video LMA insertion.
|
|
有源比较器：1 × ED95 Group
Participants receive rocuronium 0.3 mg/kg (1 × ED95) before video LMA insertion.
|
Rocuronium 0.3 mg/kg (1 × ED95) is administered intravenously before video LMA insertion.
|
|
有源比较器：2 × ED95 Group
Participants receive rocuronium 0.6 mg/kg (2 × ED95) before video LMA insertion.
|
Rocuronium 0.6 mg/kg (2 × ED95) is administered intravenously before video LMA insertion.
|
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 |
|---|---|---|
|
Oropharyngeal Leak Pressure (OLP)
大体时间：5 minutes after successful video LMA insertion
|
Oropharyngeal leak pressure will be measured 5 minutes after successful video LMA insertion and compared among the three neuromuscular blockade groups.
OLP is expressed in cmH2O.
|
5 minutes after successful video LMA insertion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oropharyngeal Leak Pressure at Later Time Points
大体时间：15 and 30 minutes after successful video LMA insertion
|
15 and 30 minutes after successful video LMA insertion
|
|
|
Number of LMA Insertion Attempts
大体时间：During anesthetic induction before surgery, assessed for up to 5 minutes
|
The number of attempts required for successful video LMA insertion will be recorded.
A maximum of two insertion attempts is permitted.
Failure will be recorded if successful insertion is not achieved after two attempts.
|
During anesthetic induction before surgery, assessed for up to 5 minutes
|
|
LMA Insertion Time
大体时间：During anesthetic induction before surgery, assessed for up to 5 minutes
|
LMA insertion time will be measured in seconds from mouth opening to confirmation of the first capnographic waveform.
|
During anesthetic induction before surgery, assessed for up to 5 minutes
|
|
Laryngeal View Grade
大体时间：Immediately after successful video LMA insertion
|
The laryngeal view obtained through the video LMA will be graded on a 4-point scale.
The need for real-time adjustment and any change in laryngeal view after adjustment will also be recorded.
|
Immediately after successful video LMA insertion
|
|
Neuromuscular Blockade at LMA Insertion
大体时间：Immediately before video LMA insertion
|
Neuromuscular response will be recorded immediately before video LMA insertion using train-of-four monitoring, including TOF count and/or quantitative twitch response according to the available monitor.
|
Immediately before video LMA insertion
|
|
Number of Participants With Sore Throat, Hoarseness, and Dysphagia
大体时间：Postoperatively in the PACU and at 24 hours after surgery
|
The presence or absence of sore throat, hoarseness, and dysphagia will be assessed separately for each participant.
|
Postoperatively in the PACU and at 24 hours after surgery
|
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。
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 (估计的)
2026年9月7日
初级完成 (估计的)
2027年2月28日
研究完成 (估计的)
2027年8月30日
研究注册日期
首次提交
2026年9月4日
首先提交符合 QC 标准的
2026年9月15日
首次发布 (实际的)
2026年9月18日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月15日
最后验证
2026年9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.