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

NCT07581665 | Not Yet Recruiting Phase 4

• 1 other identifier: IIT2026026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Anesthesia; General Anesthesia; LMA; Airway Management

Keywords

Alfentanil; Propofol; Pediatric Anesthesia; LMA; Dixon Method; Effective dose

Outcome Measures

Primary Outcomes (1)

• Success of LMA insertion

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

  Intraoperative (During LMA insertion procedure)

Secondary Outcomes (8)

• Time required for LMA insertion

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

• Number of LMA insertion attempts

  Intraoperative (during the anesthesia induction phase).

• Airway Responses

  During and up to 1 minute post-insertion

• 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.

Study Arms (1)

Alfentanil Sequential Dose Group

EXPERIMENTAL

Drug: Alfentanil

Interventions

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).

Alfentanil Sequential Dose Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Alfentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Rui Zhang, M.D.

CONTACT

+86 15802025520; zhangr52@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)