Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children
NCT07581665 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-12
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
- Airway Management
- General Anesthesia
- LMA
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).
Sponsors & Collaborators
-
Zhongshan Ophthalmic Center, Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 7 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2026-08-30
- Completion
- 2027-03-30
Countries
- China
Study Locations
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