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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-12
SponsorHuazhong University of Science and Technology

About this trial

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 criteria

Qualifiers

American Society of Anesthesiologists (ASA) physical status I or II

Aged 1 to 12 years

Scheduled for elective surgery requiring general anesthesia with laryngeal mask airway (LMA) insertion (e.g., ophthalmic surgery, skin lesion excision, minor abdominal or urological procedures, with expected surgical duration ≤ 2 hours)

Written informed consent obtained from parents or legal guardians

Disqualifiers

Known allergy or hypersensitivity to ciprofol, fentanyl, or any study-related drugs

Intellectual disability, cognitive-affective disorders, psychiatric or neurological diseases

Inability to cooperate with peripheral intravenous cannulation

History of reactive airway disease or suspected difficult airway

Trial design

Treatments tested in this trial

  • Ciprofol
  • Fentanyl

Treatment groups

180 Participants
are divided into 3 treatment groups