Ciprofol and Fentanyl for LMA Insertion in Children: Finding the ED95 Dose

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-blind, biased-coin dose-finding trial aims to identify the ED95 of a single IV bolus of ciprofol when used with a fixed fentanyl dose (1 μg/kg) for LMA insertion during pediatric anesthesia induction. 180 ASA I–II children aged 1–12 years are enrolled and divided into three age groups (1–3, 4–6, 7–12) of 60 each. Ciprofol is administered over 1 minute with up-down biased-coin dosing to adjust the next patient's dose based on the prior outcome. LMA insertion is attempted 90 seconds after drug administration and assessed for movement, jaw tightness, coughing, gagging, or laryngospasm. The design preserves blinding for the evaluator and the LMA inserter while the administering anesthesiologist knows the dose. Primary outcomes focus on successful LMA insertion without adverse responses.

Why it matters

Who can join: the full rules

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

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Li Xu
• Email: li_xu717@hust.edu.cn
• Phone: +862783663173

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.