About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 7 to 12 years
Undergoing elective day surgery
ASA physical status I-II
Body Mass Index (BMI) between 14 and 24 kg/m²
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Alfentanil
DrugAll 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).
Treatment groups
Trial outcomes
Primary outcomes
Success of LMA insertion
Assessed by the absence of body movement, coughing, breath-holding, severe hemodynamic changes, or insertion difficulty.
Secondary outcomes
Time required for LMA insertion
The time (in seconds) from picking up the LMA to the first successful breath as confirmed by capnography.
Number of LMA insertion attempts
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.
Airway Responses
Incidence and severity of body movement, cough, breath-holding, and laryngospasm.
Changes in Heart Rate (HR)
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).
Sponsors and contacts
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