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Not yet recruiting NCT07581665

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

Phase IV Interventional Pediatric Anesthesia Airway Management General Anesthesia LMA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alfentanil.
Who it may be relevant to
Registry conditions: Pediatric Anesthesia, Airway Management, General Anesthesia, LMA. Basic parameters: 7 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug 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).

Primary outcome measures

  • Success of LMA insertion [Time frame: Intraoperative (During LMA insertion procedure)]
Secondary outcome measures (8)
  • Time required for LMA insertion [Time frame: Intraoperative (from LMA pick-up to successful placement).]
  • Number of LMA insertion attempts [Time frame: Intraoperative (during the anesthesia induction phase).]
  • Airway Responses [Time frame: During and up to 1 minute post-insertion]
  • Changes in Heart Rate (HR) [Time frame: From baseline (pre-induction) up to 1 minute after LMA insertion.]
  • Changes in Mean Arterial Pressure (MAP) [Time frame: From baseline (pre-induction) up to 1 minute after LMA insertion.]
  • Awakening time [Time frame: From end of surgery up to 1 hour.]
  • Post-Anesthesia Care Unit (PACU) discharge time [Time frame: Up to PACU discharge(assessed up to 4 hours after surgery completion).]
  • Postoperative Adverse Events [Time frame: At 6 hours and 24 hours post-operation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07581665 · IIT2026026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗