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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age7-12
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Alfentanil

    Drug

    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).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Alfentanil Sequential Dose GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Success of LMA insertion

Assessed by the absence of body movement, coughing, breath-holding, severe hemodynamic changes, or insertion difficulty.

Time frame
Intraoperative (During LMA insertion procedure)

Secondary outcomes

1

Time required for LMA insertion

The time (in seconds) from picking up the LMA to the first successful breath as confirmed by capnography.

Time frame
Intraoperative (from LMA pick-up to successful placement).
2

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.

Time frame
Intraoperative (during the anesthesia induction phase).
3

Airway Responses

Incidence and severity of body movement, cough, breath-holding, and laryngospasm.

Time frame
During and up to 1 minute post-insertion
4

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).

Time frame
From baseline (pre-induction) up to 1 minute after LMA insertion.

Other outcomes

Sponsors and contacts

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