The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial

NCT07697404 | Recruiting Phase 4

• 1 other identifier: TJ-IRB202606058
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric; Anesthesia Induction; Ciprofol; Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

• 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.

  At LMA insertion, 90 seconds after drug injection

Secondary Outcomes (5)

• Incidence of adverse events within 5 minutes

  Within 5 minutes after drug injection

• mean arterial pressure (MAP)

  from before induction to 1 minute afte LMA insertion

• heart rate

  from before induction to 1 minute afte LMA insertion

• Bispectral Index (BIS)

  From before induction to 1 minute afte LMA insertion

• Pediatric Anesthesia Emergence Delirium (PAED) scale score

  Within 15-30 minutes in PACU

Study Arms (3)

Toddlers (1-3 years)

EXPERIMENTAL

Drug: Ciprofol; Drug: Fentanyl

Preschoolers (4-6 years)

EXPERIMENTAL

Drug: Ciprofol; Drug: Fentanyl

School-age (7-12 years)

EXPERIMENTAL

Drug: Ciprofol; Drug: Fentanyl

Interventions

Ciprofol DRUG

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.

Preschoolers (4-6 years); School-age (7-12 years); Toddlers (1-3 years)

Fentanyl DRUG

All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol

Preschoolers (4-6 years); School-age (7-12 years); Toddlers (1-3 years)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Li Xu

CONTACT

+862783663173; li_xu717@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 13, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): July 2, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)