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