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

RecruitingPhase 4Ages 1 Year - 12 YearsAllHuazhong University of Science and Technology
NCT07697404 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Body mass index (BMI) ≥ 30 kg/m² or ≤ 15 kg/m² * History of sedative medication use * Inability to understand the study protocol or participation in another clinical trial within the past 30 days
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What it tests

  • Ciprofol
  • Fentanyl
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Where

1 site
Tongji Hospital
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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