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

NCT07581665 · tracked via the Priya Life Science China tracker

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Phase

Phase 4

Started

2026-05-01

Last updated

2026-05-12

Condition(s) studied

Pediatric AnesthesiaAirway ManagementGeneral AnesthesiaLMA

Investigational drug(s) / intervention(s)

Alfentanil

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).

Study summary

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

Sex

ALL

Min age

7 Years

Max age

12 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07581665 on ClinicalTrials.gov ↗ ← All trials in China