PediatricPhase 4NCT07697404
The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial
A Phase 4 study testing Ciprofol and Fentanyl in people with Pediatric and Anesthesia Induction, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pediatric, Anesthesia Induction, Ciprofol
- What is being tested?
- Ciprofol and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 1 Dec 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Li Xu, li_xu717@hust.edu.cn
About this study
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.
Read the detailed description
This is a prospective, single-blind (participant and outcomes assessor-blinded), biased-coin design up-and-down sequential allocation trial. A total of 180 pediatric patients (ASA I-II) scheduled for elective surgery requiring LMA insertion will be enrolled and divided into three age groups: toddlers (1-3 years), preschoolers (4-6 years), and school-age children (7-12 years), with 60 patients per group.
All 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.
The study employs a single-blind design: the anesthesiologist who administers the study drug is aware of the ciprofol dose, whereas the anesthesiologist who performs the LMA insertion and the observer who evaluates the patient's response are both blinded to the dose assignment. LMA insertion will be attempted 90 seconds after drug administration. Successful insertion is defined as the absence of jaw tightness, gross purposeful movement, coughing, gagging, or laryngospasm during LMA insertion and cuff inflation. The primary outcome is the ED95 of ciprofol for successful LMA insertion in each age group, estimated using isotonic regression with bootstrap resampling.
- Conditions
- Pediatric, Anesthesia Induction, Ciprofol, Laryngeal Mask Airway
- Being tested
- Ciprofol, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
All 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.
FentanylDrug
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol
| Study group | Role | What they receive |
|---|---|---|
| Toddlers (1-3 years) | Experimental | Not described Receives: Drug: Ciprofol; Drug: Fentanyl |
| Preschoolers (4-6 years) | Experimental | Not described Receives: Drug: Ciprofol; Drug: Fentanyl |
| School-age (7-12 years) | Experimental | Not described Receives: Drug: Ciprofol; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At LMA insertion, 90 seconds after drug injection
Secondary outcomes (5)
Incidence of adverse events within 5 minutes
Measured: Within 5 minutes after drug injection
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)
Measured: from before induction to 1 minute afte LMA insertion
heart rate
T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
Measured: from before induction to 1 minute afte 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)
Measured: From before induction to 1 minute afte LMA insertion
Pediatric Anesthesia Emergence Delirium (PAED) scale score
Measured: Within 15-30 minutes in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Jun 2026
- Primary completion2 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697404
- Sponsor's protocol ID
- TJ-IRB202606058
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No