RecruitingPhase 4NCT07697404

The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial

Sponsor

Huazhong University of Science and Technology

Enrollment

180 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

Pediatric Anesthesia Induction Ciprofol Laryngeal Mask Airway

Summary

Ciprofol is a novel intravenous anesthetic with a pharmacological profile similar to propofol but with a lower incidence of injection pain, hypotension, and respiratory depression. For pediatric day-case surgeries, laryngeal mask airway (LMA) insertion without neuromuscular blockers is increasingly preferred. While opioids are often combined with hypnotics to optimize insertion conditions, the optimal bolus dose of ciprofol when co-administered with a standard dose of fentanyl for LMA insertion in children remains unknown. This study aims to determine the 95% effective dose (ED95) of a single intravenous bolus of ciprofol, combined with a fixed dose of fentanyl (1 μg/kg), for successful LMA insertion in children aged 1-12 years during general anesthesia induction.

Eligibility

Min Age: 1 YearMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ciprofol and a drug called Fentanyl for people with anesthesia induction, ciprofol, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 1 Year to 12 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCiprofol

All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute. The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg. The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053. If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.

DRUGFentanyl

All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol