Determining the Effective Dose of Ciprofol with Fentanyl for Laryngeal Mask Airway Insertion During General Anesthesia in Children Ages 1 to 12

What this Trial Is About

Researchers are investigating the effective dose of ciprofol, a new intravenous anesthetic similar to propofol but with fewer side effects, for children aged 1 to 12 years undergoing elective surgeries that require laryngeal mask airway LMA insertion during general anesthesia. The study aims to find the 95% effective dose ED95 of ciprofol when combined with a fixed dose of fentanyl 1 gkg to optimize LMA insertion without the use of neuromuscular blockers. This phase 4, single-blind trial enrolls pediatric patients divided into three age groups toddlers, preschoolers, and school-age children. Participants receive a predetermined intravenous bolus dose of ciprofol administered over one minute along with fentanyl. The initial ciprofol dose is 0.35 mgkg and adjusted by a biased-coin design based on the success or failure of LMA insertion, which is attempted 90 seconds after drug administration. The study monitors insertion success defined by the absence of jaw tightness or movement and uses isotonic regression with bootstrap resampling to estimate the effective dose for each age group. During the trial, participants are assessed for vital signs including mean arterial pressure, heart rate, and Bispectral Index from before induction to one minute after LMA insertion. Adverse events within five minutes, as well as emergence delirium scores in the recovery area, are also recorded. The study evaluates the primary outcome of ED95 for ciprofol and monitors secondary outcomes related to safety and anesthesia quality throughout the procedure and recovery period.

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