The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin… (NCT07697404) | Clinical Trial Compass
RecruitingPhase 4
The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial
China180 participantsStarted 2026-06-15
Plain-language summary
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.
Who can participate
Age range
1 Year – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ED95 of ciprofol for LMA insertion in children
Timeframe: At LMA insertion, 90 seconds after drug injection
Trial details
NCT IDNCT07697404
SponsorHuazhong University of Science and Technology