NCT07697404 The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial
| NCT ID | NCT07697404 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Pediatric |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2028-07-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 180 participants in total. It began in 2026-06-15 with a primary completion date of 2028-07-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07697404 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 12 Years, studying Pediatric. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07697404 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07697404 currently recruiting?
Yes, NCT07697404 is actively recruiting participants. Contact the research team at li_xu717@hust.edu.cn for enrollment information.
Where is the NCT07697404 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07697404 clinical trial?
NCT07697404 is sponsored by Huazhong University of Science and Technology. The trial plans to enroll 180 participants.