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.
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
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
Single group
Ciprofol
DrugAll 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.
Fentanyl
DrugAll patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol
ED95 of ciprofol for LMA insertion in children
The ED95 of ciprofol (combined with fentanyl 1 μg/kg) for successful LMA insertion, defined as absence of movement, coughing, gagging, or laryngospasm during insertion and cuff inflation.
Incidence of adverse events within 5 minutes
mean arterial pressure (MAP)
blood pressure were documented at the following time points: T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
heart rate
T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
Bispectral Index (BIS)
BIS values were documented at the following time points: T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
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