Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children: A Prospective, Up-and-Down Sequential Allocation Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Success of LMA insertion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Alfentanil Sequential Dose Group
干预措施: Alfentanil (Drug)
结局指标
主要结局
Success of LMA insertion
时间窗: Intraoperative (During LMA insertion procedure)
Assessed by the absence of body movement, coughing, breath-holding, severe hemodynamic changes, or insertion difficulty.
次要结局
- Airway Responses(During and up to 1 minute post-insertion)
- Time required for LMA insertion(Intraoperative (from LMA pick-up to successful placement).)
- Number of LMA insertion attempts(Intraoperative (during the anesthesia induction phase).)
- Changes in Heart Rate (HR)(From baseline (pre-induction) up to 1 minute after LMA insertion.)
- Changes in Mean Arterial Pressure (MAP)(From baseline (pre-induction) up to 1 minute after LMA insertion.)
- Awakening time(From end of surgery up to 1 hour.)
- Post-Anesthesia Care Unit (PACU) discharge time(Up to PACU discharge(assessed up to 4 hours after surgery completion).)
- Postoperative Adverse Events(At 6 hours and 24 hours post-operation)
研究者
Rui Zhang
Associate Chief Physician
Zhongshan Ophthalmic Center, Sun Yat-sen University