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Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children

2026年5月5日 更新者：Rui Zhang、Zhongshan Ophthalmic Center, Sun Yat-sen University

Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children: A Prospective, Up-and-Down Sequential Allocation Study

This study uses a prospective, up-and-down sequential allocation method to determine the median effective dose (ED50) and 95% effective dose (ED95) of alfentanil combined with propofol for successful laryngeal mask airway (LMA) insertion in children aged 7-12 undergoing elective day surgery.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Laryngeal mask airway (LMA) insertion is a common practice in pediatric day surgery. While it is less invasive than endotracheal intubation, children exhibit high airway reactivity, requiring an optimal depth of anesthesia to suppress airway reflexes. Alfentanil is an opioid with a rapid onset and short duration of action, making it potentially ideal for LMA insertion. However, current dosage recommendations for alfentanil are often extrapolated from tracheal intubation studies, which may lead to overdosage, respiratory depression, or delayed recovery in children. This study aims to determine the precise effective dose (ED50 and ED95) of alfentanil when combined with a fixed dose of propofol for smooth LMA insertion in children.

研究类型

介入性

注册 (估计的)

40

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

学习地点

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University
        • 接触：

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

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged 7 to 12 years
  • Undergoing elective day surgery
  • ASA physical status I-II
  • Body Mass Index (BMI) between 14 and 24 kg/m²
  • Accompanied by a fully capable guardian within 24 hours after discharge

Exclusion Criteria:

  • Allergy to opioids
  • Unresolved upper respiratory tract infection within the past 1 week
  • Abnormal heart, lung, liver, or kidney function, or metabolic diseases
  • Airway anatomical abnormalities (e.g., micrognathia, laryngomalacia, macroglossia) or OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome)
  • Use of analgesics, sedatives, or other psychotropic drugs within the past 2 weeks
  • Refusal to sign the informed consent form

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：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Alfentanil Sequential Dose Group
药品：Alfentanil
All patients receive 2.5 mg/kg propofol injected over 30 seconds. Alfentanil is administered 1 minute prior to propofol. The dose is adjusted by steps of 2 µg/kg based on the previous patient's response (successful insertion = decrease dose; failed insertion = increase dose).

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
Success of LMA insertion
大体时间：Intraoperative (During LMA insertion procedure)
Assessed by the absence of body movement, coughing, breath-holding, severe hemodynamic changes, or insertion difficulty.
Intraoperative (During LMA insertion procedure)

次要结果测量

结果测量
措施说明
大体时间
Time required for LMA insertion
大体时间：Intraoperative (from LMA pick-up to successful placement).
The time (in seconds) from picking up the LMA to the first successful breath as confirmed by capnography.
Intraoperative (from LMA pick-up to successful placement).
Number of LMA insertion attempts
大体时间：Intraoperative (during the anesthesia induction phase).
The total number of attempts required to successfully place the LMA. An attempt is defined as the introduction of the LMA into the patient's mouth.
Intraoperative (during the anesthesia induction phase).
Airway Responses
大体时间：During and up to 1 minute post-insertion
Incidence and severity of body movement, cough, breath-holding, and laryngospasm.
During and up to 1 minute post-insertion
Changes in Heart Rate (HR)
大体时间：From baseline (pre-induction) up to 1 minute after LMA insertion.
Evaluation of heart rate (beats per minute) to assess hemodynamic stability at four time points: T0 (baseline), T1 (post-induction), T2 (immediate post-insertion), and T3 (1 min post-insertion).
From baseline (pre-induction) up to 1 minute after LMA insertion.
Changes in Mean Arterial Pressure (MAP)
大体时间：From baseline (pre-induction) up to 1 minute after LMA insertion.
Evaluation of mean arterial pressure (mmHg) to assess hemodynamic stability at four time points: T0 (baseline), T1 (post-induction), T2 (immediate post-insertion), and T3 (1 min post-insertion).
From baseline (pre-induction) up to 1 minute after LMA insertion.
Awakening time
大体时间：From end of surgery up to 1 hour.
The interval from the discontinuation of anesthetic agents to the moment the patient follows simple commands or opens eyes.
From end of surgery up to 1 hour.
Post-Anesthesia Care Unit (PACU) discharge time
大体时间：Up to PACU discharge(assessed up to 4 hours after surgery completion).
The duration (in minutes) from arrival in the PACU until the patient meets discharge criteria.
Up to PACU discharge(assessed up to 4 hours after surgery completion).
Postoperative Adverse Events
大体时间：At 6 hours and 24 hours post-operation
Incidence of PONV (postoperative nausea and vomiting), sore throat, and hoarseness.
At 6 hours and 24 hours post-operation

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。

赞助

Zhongshan Ophthalmic Center, Sun Yat-sen 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 (估计的)

2026年5月1日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2027年3月30日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IIT2026026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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